Buffer Solution (pH 9.18)

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Buffer Solution (pH 9.18) is a sterile, ready-to-use liquid reagent with a precisely known pH value of 9.18 at 25°C, specifically formulated for the calibration and quality control of pH meters, pH electrodes, and automated analyzers in the alkaline range for clinical diagnostic and research laboratories. The solution is composed of sodium tetraborate decahydrate (borax) in purified water, manufactured under ISO/IEC 17025 and ISO 17034 accreditation with traceability to NIST standard reference materials and PTB primary certified reference standards.

For the clinical laboratory scientist and medical technologist, Buffer Solution (pH 9.18) serves as the alkaline calibration standard for three-point pH meter calibration (in conjunction with pH 6.86 and pH 4.00 buffers), ensuring accurate pH measurement of alkaline biological specimens including urine, pancreatic fluid, and certain diagnostic reagents. The solution is measured using a combined glass electrode following a 5-point calibration method, compliant with DIN 19268, NIST, IUPAC, Ph. Eur, and USP standards. Each batch is accompanied by a detailed and batch-specific certificate of analysis (CoA) containing lot number, measured pH value, pH/temperature table (9.22 at 20°C, 9.18 at 25°C, 9.14 at 30°C, 9.09 at 37°C), uncertainty (±0.02 pH), and expiration date.

The solution is classified as a Class I Medical Device (FDA Product Code JCC – General Purpose Reagent) and is 510(K) exempt, with GMP exempt status when not labeled as sterile. pH 9.18 buffer solution is available in various packaging formats including 30 mL sachets, 60 mL bottles, 100 mL bottles, 500 mL bottles, and 1 L bottles. Some manufacturers color-code the solution for easy identification (e.g., blue or clear depending on the brand), and a pH/temperature table is printed on the label for accurate calibrations at different temperatures. The unopened shelf life is 2 years when stored at room temperature (15-25°C); once opened, the solution should be used within 90 days.

For the patient undergoing diagnostic testing for metabolic alkalosis, renal tubular acidosis, pancreatic function disorders, or other conditions requiring alkaline pH measurement, accurate pH measurement of biological fluids—verified through proper three-point calibration using certified pH 9.18 buffer—ensures reliable test results that guide appropriate treatment decisions across clinical chemistry, urinalysis, pancreatic function testing, and pharmaceutical quality control applications.

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Categories: CONSUMABLES AND DISPOSABLES, Injection and Infusion Tags: Alkaline pH Calibration Standard, Borax Buffer, Borax Buffer Solution, Buffer Solution (pH 9.18), Clinical Chemistry Reagent, General Purpose Reagent, NIST Traceable Buffer, pH Calibration Buffer, pH Meter Calibration, pH Reference Standard

Description

Buffer Solution (pH 9.18)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Calibration of pH Meters for Accurate Diagnostic Testing

Primary Use: Provides a sterile, ready-to-use solution with a precisely known pH value of 9.18 at 25°C, used as a calibration standard for pH meters and pH electrodes to ensure accurate pH measurement of alkaline biological specimens and diagnostic reagents.
How it helps: For the clinical laboratory scientist, medical technologist, and quality control officer, the pH 9.18 buffer solution serves as the alkaline calibration standard, typically used as the third calibration point in three-point calibration protocols (pH 6.86, pH 4.00, and pH 9.18 buffers). The solution is gravimetrically prepared at ISO/IEC 17025 accredited laboratories using sodium tetraborate decahydrate (borax) with an uncertainty of ±0.02 pH. For the patient, accurate pH measurement of alkaline biological fluids (such as urine, pancreatic fluid, and diagnostic reagents) ensures reliable diagnosis of metabolic alkalosis, renal tubular acidosis, and other acid-base disorders.

2. Verification of pH Electrode Performance in Alkaline Range

Primary Use: Used to verify the slope, response time, and accuracy of pH electrodes and pH meters in the alkaline pH range during routine quality control procedures before patient sample testing.
How it helps: For the clinical laboratory scientist and quality assurance manager, measuring a pH 9.18 buffer solution as an external quality control standard provides objective evidence that the pH electrode is functioning within acceptable parameters in the alkaline range. The solution is measured using a combined glass electrode following a 5-point calibration method, compliant with DIN 19268 and reference buffer standards including NIST, IUPAC, Ph. Eur, and USP. For the patient, routine verification of pH electrode performance with certified buffer solutions ensures that pH measurements used for clinical decision-making are accurate and reproducible across the entire pH range.

3. Alkaline Calibration Point for Acid-Base Balance Testing

Primary Use: Employed as the alkaline calibration point during three-point calibration (pH 6.86, pH 4.00, and pH 9.18) of pH meters used in clinical laboratories for measuring alkaline patient specimens.
How it helps: For the medical technologist and clinical chemist, the pH 9.18 buffer is specifically indicated for calibrating pH meters when measuring alkaline samples (pH > 7.00). Using the buffer as a calibration standard corrects for the alkaline portion of the electrode response curve, ensuring accurate measurement of patient specimens with pH values above neutrality. For the patient undergoing diagnostic testing for conditions that require precise alkaline pH measurement (such as pancreatic function testing or urinary alkalinization monitoring), proper three-point calibration using pH 9.18 buffer ensures that test results accurately reflect the patient’s clinical status.

4. Quality Control and Regulatory Compliance

Primary Use: Serves as a certified reference material for Good Laboratory Practice (GLP) compliance, with traceability to NIST (National Institute of Standards and Technology) standard reference materials and PTB primary certified reference standards.
How it helps: For the laboratory quality manager and regulatory compliance officer, pH 9.18 buffer solutions manufactured under ISO 17025 and ISO 17034 accreditation provide documented traceability to primary reference standards. Each batch is accompanied by a detailed and batch-specific certificate of analysis (CoA) containing lot number, measured pH value, uncertainty (±0.02 pH), and expiration date, supporting regulatory compliance for GLP, CAP, CLIA, and ISO 15189 standards. For the patient, the use of certified, traceable buffer solutions in clinical laboratory quality assurance programs ensures that pH measurements meet regulatory requirements for accuracy and reliability.

5. Verification of Blood Gas and Electrolyte Analyzers

Primary Use: Used to verify the pH channel accuracy of blood gas analyzers and electrolyte analyzers during quality control procedures in critical care settings, particularly for alkaline blood samples.
How it helps: For the critical care laboratory scientist and point-of-care coordinator, pH 9.18 buffer solution is employed as a quality control material to verify the performance of blood gas analyzers that measure pH in arterial blood samples, particularly when monitoring patients with metabolic alkalosis. The buffer helps confirm that the instrument’s pH channel is within acceptable limits across the alkaline range before patient sample analysis. For the critically ill patient requiring arterial blood gas monitoring for assessment of metabolic alkalosis, respiratory disorders, or acid-base disturbances, accurate pH measurement verified with certified buffer solutions ensures appropriate ventilator settings, medication adjustments, and clinical interventions.

SECONDARY & SUPPORTIVE USES

1. Routine Laboratory Quality Control: Used as an external quality control standard to monitor pH meter performance between calibrations, ensuring ongoing accuracy throughout the testing day, particularly for alkaline sample measurements.

2. Electrode Storage and Conditioning: Some pH electrodes require periodic soaking in pH 9.18 buffer to condition the glass membrane and maintain optimal response time, particularly for electrodes used in alkaline sample measurement applications.

3. Verification of pH Test Strips and Colorimetric Methods: Used as a standard to verify the accuracy of pH test strips, pH paper, and colorimetric pH test kits used in clinical laboratories and point-of-care settings for alkaline range measurements.

4. System Suitability Testing for Pharmaceutical Analysis: Employed in pharmaceutical quality control laboratories as a system suitability standard for pH measurement during drug stability testing, dissolution testing, and formulation development for alkaline pharmaceutical preparations.

5. Validation of Automated Analyzer pH Channels: Used during installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of automated clinical chemistry analyzers with integrated pH measurement capabilities.

6. Academic and Educational Laboratory Training: Serves as a teaching standard for training medical technology students and clinical laboratory science trainees in proper pH meter calibration and measurement techniques in the alkaline range.

7. Research and Development pH Measurement: Used as a calibration standard in research laboratories for pH measurement during drug discovery, biomaterial development, and tissue engineering research involving alkaline conditions.

8. Environmental and Water Quality Testing: Employed in hospital environmental monitoring programs to calibrate pH meters used for testing alkaline wastewater discharge and treated water from certain industrial processes.

9. Dissolution Testing for Alkaline Formulations: Used in pharmaceutical dissolution testing to prepare pH-specific dissolution media for alkaline drug formulations and to verify the pH of dissolution apparatus vessels.

10. Buffer Capacity Verification: Used to verify the buffer capacity of laboratory-prepared alkaline buffers and to check the performance of pH electrodes in alkaline solutions.

11. Temperature Verification of pH Systems: The temperature-dependent relationship of pH 9.18 buffer (pH value decreases as temperature increases) is printed on the product label as a pH/temperature table for accurate calibrations at different temperatures.

12. Inter-Laboratory Comparison Studies: Used as a blind sample in proficiency testing and inter-laboratory comparison studies to evaluate the accuracy of pH measurements across different laboratories in the alkaline range.

13. Custom Buffer Preparation: Employed as a starting standard for preparing custom alkaline buffer solutions with specific pH requirements for specialized diagnostic applications.

14. Troubleshooting pH Electrode Issues: Used to diagnose electrode problems by comparing the measured pH of fresh buffer to the expected value; deviation in the alkaline range indicates electrode contamination, aging, or damage requiring maintenance or replacement.

15. Validation of pH Meter Repairs: Used after pH meter repair or maintenance to verify instrument alkaline range accuracy before returning to clinical service.

16. Pharmaceutical Clean-in-Place (CIP) Verification: Used to verify the pH of alkaline cleaning solutions in pharmaceutical manufacturing clean-in-place systems.

17. Buffer Solution for Specific Ion Meter Calibration: pH 9.18 buffer may be used in conjunction with ion-selective electrode (ISE) calibration for certain analytes when alkaline pH adjustment is required.

18. Food and Beverage Quality Control: Used in hospital nutrition services and food safety testing to verify pH of alkaline foods, beverages, and nutritional supplements.

19. Pancreatic Function Testing Quality Control: Used in quality control procedures for pancreatic function tests that require precise alkaline pH measurement of collected specimens.

20. Facial Skin Protection: The distinctive color-coding of pH 9.18 buffer (often blue or clear depending on manufacturer) aids in easy visual identification and prevents buffer solution mix-ups in high-volume testing environments.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A sterile, ready-to-use liquid solution with a precisely known pH value of 9.18 at 25°C, used for calibration and quality control of pH measuring instruments in the alkaline range for clinical diagnostic laboratories.
Designation: pH 9.18 Buffer Solution, Borax Buffer Solution, Alkaline pH Calibration Standard, pH Reference Standard, pH Calibration Buffer, Alkaline Calibration Solution.
Key Components:
- Active Ingredient: Sodium tetraborate decahydrate (Na₂B₄O₇·10H₂O / borax) – the primary buffering agent.
- Solvent: Purified water (>98% of solution).
- Preservative: Methylparaben or other preservative to prevent microbial growth.
- Color Additive: May be colorless or color-coded (e.g., blue, clear, or colorless depending on manufacturer).

2. TECHNICAL & PERFORMANCE PROPERTIES

pH Value: 9.18 ± 0.01 to ± 0.05 at 25°C (depending on grade and manufacturer).
pH Value at 20°C: 9.22.
pH Value at 30°C: 9.14.
pH Value at 37°C: 9.09.
Composition: Sodium tetraborate decahydrate (borax).
Concentration: Gravimetrically prepared at registered calibration laboratory.
Measurement Method: 5-point calibration using combined glass electrode according to DIN 19268.
Compliance Standards: DIN 19266, NIST, IUPAC, Ph. Eur, and USP.
Traceability: Traceable to NIST standard reference materials (SRMs) and PTB primary certified reference standards.
Uncertainty: ±0.02 pH at 25°C.
Appearance: Clear, colorless or color-coded liquid.
Odor: Odorless.
Shelf Life (Unopened): 2 years.
Shelf Life (Opened): Use within 90 days for pH 9.18 buffer.
Storage Temperature: 15-25°C (room temperature); avoid freezing.
pH Temperature Dependency: pH value varies with temperature (decreases as temperature increases); pH/temperature table printed on product label for accurate calibrations.
Manufacturing Accreditation: ISO/IEC 17025 and ISO 17034 accredited.
Quality Level: Certified reference material grade available.
Regulatory Classification: FDA Product Code JCC – General Purpose Reagent; Class I Medical Device.
GMP Status: Exempt from GMP regulations when not labeled or represented as sterile.
Regulation Number: 21 CFR 864.4010.
GMDN Term Code: 42693 – pH-adjusted buffer solution IVD.

3. PHYSICAL & OPERATIONAL PROPERTIES

Physical Form: Liquid with low viscosity.
Container Types: Available in various packaging formats including 30 mL sachets, 60 mL bottles, 100 mL bottles, 250 mL bottles, 500 mL bottles, 1 L bottles, and 5 x 60 mL convenience packs.
Color Coding: Rainbow bottle design with specific color for each pH value; pH 9.18 is often blue or clear depending on manufacturer.
Ready-to-Use: No preparation or dilution required; use directly from container.
Temperature Sensitivity: pH value is temperature dependent; equilibrate to room temperature or measurement temperature before use; pH/temperature table provided.
Stability After Opening: Certified buffer solutions remain stable for 90 days after opening when stored properly and protected from contamination.
Certificate of Analysis (CoA): Provided with each batch, including lot-specific pH value, measurement uncertainty, expiry date, and traceability information.
Label Information: Includes ordering number, article description, lot number, safety data, expiry date, and pH/temperature table, following ISO Guide 31.
Storage Stability: Packaging material subjected to comprehensive stability studies as per ISO Guide 35.
Shelf Life Classification: "Fair" under normal storage conditions.

4. SAFETY & COMPLIANCE ATTRIBUTES

Signal Word: CAUTION.
Hazard Classification:
- May be harmful if swallowed.
- May cause mild skin irritation.
- May cause mild eye irritation.
Flammability: Nonflammable, noncombustible solution.
Reactivity: Stable under normal storage conditions; avoid heat.
Incompatibilities: Avoid contact with strong oxidizing agents and strong acids.
Storage Conditions: Store in a cool, dry location; protect from freezing and extreme temperatures.
Regulatory Exemptions: 510(K) Exempt; GMP Exempt (except for records and complaint files) when not labeled as sterile.
Device Class: Class I Medical Device.
Sterility: Not sterile; intended for external use as a calibration standard, not for administration to patients.
Non-latex: Contains no latex components.
Alkaline pH Range: 9.18 pH is above neutrality, suitable for alkaline calibration applications.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store in a cool, dry location at room temperature (15-25°C / 59-77°F). Avoid freezing and protect from direct sunlight and extreme heat.
Shelf Life (Unopened): 2 years from date of manufacture; refer to expiration date on product label.
Shelf Life (Opened): Use within 90 days of opening for pH 9.18 buffer; discard after 90 days.
Inspection: Do not use if solution appears cloudy, contains precipitate, is discolored, or if the container is damaged.
Temperature Equilibration: Allow buffer solution to equilibrate to room temperature or measurement temperature before use, as pH value is temperature-dependent.
Usage Precautions: If using small volumes, aliquot into a clean container to avoid contaminating the main stock solution.
Electrode Preparation: Rinse pH electrode with distilled or deionized water before immersing in buffer solution.
Avoid Cross-Contamination: Do not return used buffer solution to the original container.
First Pour Usage: For critical calibrations, use the first pour of buffer solution from the bottle to ensure maximum freshness and accuracy.
Container Disposal: Dispose of empty containers according to local environmental regulations for chemical waste.
Spill Management: Ventilate area; contain spill with inert absorbent material; neutralize with dilute acid (e.g., acetic acid); collect in sealed container.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Calibration and quality control of pH meters, pH electrodes, and automated analyzers with pH measurement capabilities in the alkaline range for clinical diagnostic, pharmaceutical, and research laboratories.
Clinical Role: Essential quality control and calibration reagent in clinical chemistry laboratories, hospital laboratories, blood gas laboratories, pharmaceutical quality control labs, and research facilities for ensuring accurate pH measurement in alkaline patient sample testing.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Personal Protective Equipment: Wear appropriate PPE—laboratory coat, chemical-resistant gloves (nitrile or neoprene), and safety glasses or face shield—when handling buffer solution.
Eye Contact: If solution contacts eyes, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. If eye irritation persists, seek medical attention.
Skin Contact: Wash affected area with plenty of water. If skin irritation occurs, seek medical advice or attention.
Inhalation: If vapors are inhaled and feeling unwell, move to fresh air. Seek medical attention if symptoms persist.
Ingestion: Rinse mouth. Call a poison center or physician if feeling unwell.
Spill Response: Ventilate area. Contain spill with sand or other inert absorbent material. Neutralize with dilute acid (acetic acid). Collect in sealed bag or container. Dispose according to local regulations.
Fire Fighting Measures: Use tri-class dry chemical fire extinguisher for surrounding fires; solution itself is nonflammable.
Storage Compatibility: Store with other buffer solutions; separate from strong acids; follow laboratory chemical storage protocols.
Disposal: Dispose of the product according to relevant regulations; do not dispose of it casually.
Do Not Use For Clinical Diagnosis: This product is for research and quality control use only, not for direct patient diagnosis or treatment.
Not for Internal Use: For external use as a calibration and quality control reagent; not for injection or infusion into patients.

2. FIRST AID MEASURES

Eye Exposure: If buffer solution splashes into eyes, rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for at least 15 minutes. If irritation persists, seek medical attention.
Skin Exposure: If buffer solution contacts skin, wash with plenty of water. If skin irritation occurs, seek medical advice or attention.
Inhalation: If vapors are inhaled, move to fresh air. Seek medical attention if respiratory symptoms develop.
Ingestion: If swallowed, rinse mouth. Do not induce vomiting unless directed by medical personnel. Call a poison center or physician if feeling unwell.
Chemical Spill: If large spill occurs, contain spill, neutralize with dilute acetic acid, and dispose according to local environmental regulations.

3. FIRE FIGHTING MEASURES

Flammability: Nonflammable, noncombustible solution.
Extinguishing Media: Use tri-class dry chemical fire extinguisher for fires involving surrounding combustible materials.
Fire Response: No special fire hazards beyond typical combustible materials.

Buffer Solution (pH 9.18)

Buffer Solution (pH 9.18)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Calibration of pH Meters for Accurate Diagnostic Testing

Primary Use: Provides a sterile, ready-to-use solution with a precisely known pH value of 9.18 at 25°C, used as a calibration standard for pH meters and pH electrodes to ensure accurate pH measurement of alkaline biological specimens and diagnostic reagents.

2. Verification of pH Electrode Performance in Alkaline Range

Primary Use: Used to verify the slope, response time, and accuracy of pH electrodes and pH meters in the alkaline pH range during routine quality control procedures before patient sample testing.

3. Alkaline Calibration Point for Acid-Base Balance Testing

Primary Use: Employed as the alkaline calibration point during three-point calibration (pH 6.86, pH 4.00, and pH 9.18) of pH meters used in clinical laboratories for measuring alkaline patient specimens.

4. Quality Control and Regulatory Compliance

Primary Use: Serves as a certified reference material for Good Laboratory Practice (GLP) compliance, with traceability to NIST (National Institute of Standards and Technology) standard reference materials and PTB primary certified reference standards.

5. Verification of Blood Gas and Electrolyte Analyzers

Primary Use: Used to verify the pH channel accuracy of blood gas analyzers and electrolyte analyzers during quality control procedures in critical care settings, particularly for alkaline blood samples.

SECONDARY & SUPPORTIVE USES

1. Routine Laboratory Quality Control: Used as an external quality control standard to monitor pH meter performance between calibrations, ensuring ongoing accuracy throughout the testing day, particularly for alkaline sample measurements.

2. Electrode Storage and Conditioning: Some pH electrodes require periodic soaking in pH 9.18 buffer to condition the glass membrane and maintain optimal response time, particularly for electrodes used in alkaline sample measurement applications.

3. Verification of pH Test Strips and Colorimetric Methods: Used as a standard to verify the accuracy of pH test strips, pH paper, and colorimetric pH test kits used in clinical laboratories and point-of-care settings for alkaline range measurements.

4. System Suitability Testing for Pharmaceutical Analysis: Employed in pharmaceutical quality control laboratories as a system suitability standard for pH measurement during drug stability testing, dissolution testing, and formulation development for alkaline pharmaceutical preparations.

5. Validation of Automated Analyzer pH Channels: Used during installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of automated clinical chemistry analyzers with integrated pH measurement capabilities.

6. Academic and Educational Laboratory Training: Serves as a teaching standard for training medical technology students and clinical laboratory science trainees in proper pH meter calibration and measurement techniques in the alkaline range.

7. Research and Development pH Measurement: Used as a calibration standard in research laboratories for pH measurement during drug discovery, biomaterial development, and tissue engineering research involving alkaline conditions.

8. Environmental and Water Quality Testing: Employed in hospital environmental monitoring programs to calibrate pH meters used for testing alkaline wastewater discharge and treated water from certain industrial processes.

9. Dissolution Testing for Alkaline Formulations: Used in pharmaceutical dissolution testing to prepare pH-specific dissolution media for alkaline drug formulations and to verify the pH of dissolution apparatus vessels.

10. Buffer Capacity Verification: Used to verify the buffer capacity of laboratory-prepared alkaline buffers and to check the performance of pH electrodes in alkaline solutions.

11. Temperature Verification of pH Systems: The temperature-dependent relationship of pH 9.18 buffer (pH value decreases as temperature increases) is printed on the product label as a pH/temperature table for accurate calibrations at different temperatures.

12. Inter-Laboratory Comparison Studies: Used as a blind sample in proficiency testing and inter-laboratory comparison studies to evaluate the accuracy of pH measurements across different laboratories in the alkaline range.

13. Custom Buffer Preparation: Employed as a starting standard for preparing custom alkaline buffer solutions with specific pH requirements for specialized diagnostic applications.

14. Troubleshooting pH Electrode Issues: Used to diagnose electrode problems by comparing the measured pH of fresh buffer to the expected value; deviation in the alkaline range indicates electrode contamination, aging, or damage requiring maintenance or replacement.

15. Validation of pH Meter Repairs: Used after pH meter repair or maintenance to verify instrument alkaline range accuracy before returning to clinical service.

16. Pharmaceutical Clean-in-Place (CIP) Verification: Used to verify the pH of alkaline cleaning solutions in pharmaceutical manufacturing clean-in-place systems.

17. Buffer Solution for Specific Ion Meter Calibration: pH 9.18 buffer may be used in conjunction with ion-selective electrode (ISE) calibration for certain analytes when alkaline pH adjustment is required.

18. Food and Beverage Quality Control: Used in hospital nutrition services and food safety testing to verify pH of alkaline foods, beverages, and nutritional supplements.

19. Pancreatic Function Testing Quality Control: Used in quality control procedures for pancreatic function tests that require precise alkaline pH measurement of collected specimens.

20. Facial Skin Protection: The distinctive color-coding of pH 9.18 buffer (often blue or clear depending on manufacturer) aids in easy visual identification and prevents buffer solution mix-ups in high-volume testing environments.

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A sterile, ready-to-use liquid solution with a precisely known pH value of 9.18 at 25°C, used for calibration and quality control of pH measuring instruments in the alkaline range for clinical diagnostic laboratories.

Designation: pH 9.18 Buffer Solution, Borax Buffer Solution, Alkaline pH Calibration Standard, pH Reference Standard, pH Calibration Buffer, Alkaline Calibration Solution.

Key Components:

Active Ingredient: Sodium tetraborate decahydrate (Na₂B₄O₇·10H₂O / borax) – the primary buffering agent.

Solvent: Purified water (>98% of solution).

Preservative: Methylparaben or other preservative to prevent microbial growth.

Color Additive: May be colorless or color-coded (e.g., blue, clear, or colorless depending on manufacturer).

2. TECHNICAL & PERFORMANCE PROPERTIES

pH Value: 9.18 ± 0.01 to ± 0.05 at 25°C (depending on grade and manufacturer).

pH Value at 20°C: 9.22.

pH Value at 30°C: 9.14.

pH Value at 37°C: 9.09.

Composition: Sodium tetraborate decahydrate (borax).

Concentration: Gravimetrically prepared at registered calibration laboratory.

Measurement Method: 5-point calibration using combined glass electrode according to DIN 19268.

Compliance Standards: DIN 19266, NIST, IUPAC, Ph. Eur, and USP.

Traceability: Traceable to NIST standard reference materials (SRMs) and PTB primary certified reference standards.

Uncertainty: ±0.02 pH at 25°C.

Appearance: Clear, colorless or color-coded liquid.

Odor: Odorless.

Shelf Life (Unopened): 2 years.

Shelf Life (Opened): Use within 90 days for pH 9.18 buffer.

Storage Temperature: 15-25°C (room temperature); avoid freezing.

pH Temperature Dependency: pH value varies with temperature (decreases as temperature increases); pH/temperature table printed on product label for accurate calibrations.

Manufacturing Accreditation: ISO/IEC 17025 and ISO 17034 accredited.

Quality Level: Certified reference material grade available.

Regulatory Classification: FDA Product Code JCC – General Purpose Reagent; Class I Medical Device.

GMP Status: Exempt from GMP regulations when not labeled or represented as sterile.

Regulation Number: 21 CFR 864.4010.

GMDN Term Code: 42693 – pH-adjusted buffer solution IVD.

3. PHYSICAL & OPERATIONAL PROPERTIES

Physical Form: Liquid with low viscosity.

Container Types: Available in various packaging formats including 30 mL sachets, 60 mL bottles, 100 mL bottles, 250 mL bottles, 500 mL bottles, 1 L bottles, and 5 x 60 mL convenience packs.

Color Coding: Rainbow bottle design with specific color for each pH value; pH 9.18 is often blue or clear depending on manufacturer.

Ready-to-Use: No preparation or dilution required; use directly from container.

Temperature Sensitivity: pH value is temperature dependent; equilibrate to room temperature or measurement temperature before use; pH/temperature table provided.

Stability After Opening: Certified buffer solutions remain stable for 90 days after opening when stored properly and protected from contamination.

Certificate of Analysis (CoA): Provided with each batch, including lot-specific pH value, measurement uncertainty, expiry date, and traceability information.

Label Information: Includes ordering number, article description, lot number, safety data, expiry date, and pH/temperature table, following ISO Guide 31.

Storage Stability: Packaging material subjected to comprehensive stability studies as per ISO Guide 35.

Shelf Life Classification: "Fair" under normal storage conditions.

4. SAFETY & COMPLIANCE ATTRIBUTES

Signal Word: CAUTION.

Hazard Classification:

May be harmful if swallowed.