PHR1071

Citric acid, Anhydrous

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Citric acid
• Linear Formula: HOC(COOH)(CH₂COOH)₂
• CAS Number: 77-92-9
• Molecular Weight: 192.12
• Beilstein: 782061
• EC Number: 201-069-1
• MDL number: MFCD00011669
• UNSPSC Code: 41116107
• eCl@ss: 39021801
• PubChem Substance ID: 329823094
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. A1202000; traceable to USP 1134368
• API family: citric acid
• CofA: current certificate can be downloaded
• expl. lim.: 8 %, 65 °F
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• pKa: (1) 3.13, (2) 4.76, (3) 6.4
• mp: 153-159 °C (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: OC(=O)CC(O)(CC(O)=O)C(O)=O
• InChI: 1S/C6H8O7/c7-3(8)1-6(13,5(11)12)2-4(9)10/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
• InChI key: KRKNYBCHXYNGOX-UHFFFAOYSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Citric acid is a common ingredient in pharmaceutical formulations. It finds use in antacids and dentrifices because of the effervescent effect it generates upon combination with carbonates or bicarbonates. Citric acid may also be used as a buffering agent and it assists in the dispersion of suspensions in order to ensure the stability of the active ingredients and enhance the efficacy of antioxidants.[1]

Application

Anhydrous citric acid may be used as a reference standard in determining the concentration of citric acid present in biological fluids using spectrophotometric method.[2]

Citric acid, Anhydrous may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations[1][3][4] and milk samples[4] by various chromatography techniques.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB7603 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319,H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P304 + P340 + P312 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable