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PHR1071

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Citric acid, Anhydrous

Pharmaceutical Secondary Standard; Certified Reference Material

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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

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

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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.
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.
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.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H319,H335

Hazard Classifications

Eye Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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)
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)
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)
Konrad Hoetzenecker et al.
European heart journal, 36(11), 676-685 (2013-01-17)
Supernatants of serum-free cultured mononuclear cells (MNC) contain a mix of immunomodulating factors (secretome), which have been shown to attenuate detrimental inflammatory responses following myocardial ischaemia. Inflammatory dilated cardiomyopathy (iDCM) is a common cause of heart failure in young patients.
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