PHR1071

Supelco

Citric acid, Anhydrous

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Citric acid
Linear Formula:
HOC(COOH)(CH2COOH)2
CAS Number:
Molecular Weight:
192.12
Beilstein/REAXYS Number:
782061
EC Number:
MDL number:
eCl@ss:
39021801
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat

CofA

current certificate can be downloaded

expl. lim.

8 %, 65 °F

application(s)

HPLC: suitable
gas chromatography (GC): suitable

pKa 

(1) 3.13, (2) 4.76, (3) 6.4

mp

153-159 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to PhEur A1202000
traceable to USP 1134368

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

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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.

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

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.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

RIDADR

NONH for all modes of transport

WGK Germany

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

A simplified photometric method for the determination of citric acid in biological fluids
Ettinger.HR, et al.
The Journal of Biological Chemistry, 199(2), 531-536 (1952)
High performance liquid chromatography method for determination of methyl-5-benzoyl-2-benzimidazole carbamate (mebendazole) and its main degradation product in pharmaceutical dosage forms
Al-Kurdi Z, et al.
Talanta, 50(5), 1089-1097 (1999)
Development and validation of an assay for citric acid/citrate and phosphate in pharmaceutical dosage forms using ion chromatography with suppressed conductivity detection
DeBorba BM, et al.
Journal of Pharmaceutical and Biomedical Analysis, 36(3), 517-524 (2004)
Liquid chromatographic determination with fluorescence detection of B6 vitamers and riboflavin in milk and pharmaceuticals
Gatti R and Gioia MG
Analytica Chimica Acta, 538(1-2), 135-141 (2005)
Wayne B Batchelor et al.
Circulation, 106(12), 1470-1476 (2002-09-18)
The relative anti-aggregatory effects of currently prescribed platelet glycoprotein IIb/IIIa receptor antagonists during and after percutaneous coronary intervention for acute coronary syndromes have not been established. We randomized 70 acute coronary syndrome patients undergoing percutaneous coronary intervention to receive abciximab...
Protocols
Separation of Pyruvic acid, United States Pharmacopeia (USP) Reference Standard; Tartaric acid, United States Pharmacopeia (USP) Reference Standard; Citric acid, United States Pharmacopeia (USP) Reference Standard; Malic acid, United States Pharmacopeia (USP) Reference Standard; L-Pyroglutamic acid, ≥99.0% (T); Lactic acid, United States Pharmacopeia (USP) Reference Standard; Acetic acid, ≥99.99% trace metals basis; Succinic acid, United States Pharmacopeia (USP) Reference Standard
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