PHR1273

Malic acid

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): DL-Hydroxybutanedioic acid, DL-Malic acid, (±)-2-Hydroxysuccinic acid
• Linear Formula: HO₂CCH₂CH(OH)CO₂H
• CAS Number: 6915-15-7
• Molecular Weight: 134.09
• Beilstein/REAXYS Number: 1723539
• EC Number: 230-022-8
• MDL number: MFCD00064212
• PubChem Substance ID: 329823269
• E Number: E296
• NACRES: NA.24

Properties

• Quality Level: 300
• grade: certified reference material; pharmaceutical secondary standard
• vapor density: 4.6 (vs air)
• vapor pressure: <0.1 mmHg ( 20 °C)
• form: neat
• CofA: current certificate can be downloaded
• autoignition temp.: 644 °F
• application(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 131-133 °C (lit.)
• Featured Industry: Cleaning Products; Cosmetics; Food and Beverages; Personal Care; Pharmaceutical (small molecule)
• format: neat
• pharmacopeia traceability: traceable to PhEur Y0000143; traceable to USP 1374601
• SMILES string: OC(CC(O)=O)C(O)=O
• InChI: 1S/C4H6O5/c5-2(4(8)9)1-3(6)7/h2,5H,1H2,(H,6,7)(H,8,9)
• InChI key: BJEPYKJPYRNKOW-UHFFFAOYSA-N

Description

General description

Malic acid is a naturally occurring acidulant and low acid food additive, present in most fruits and vegetables. It is widely used to enhance the flavor, adjust the pH value of alkaline products and to control the growth of bacteria.

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.

Application

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 LRAA0009 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H319
• Precautionary Statements: P264 - P280 - P305 + P351 + P338 - P337 + P313
• Hazard Codes: Xi
• Risk Statement: 36
• Safety Statement: 26
• RIDADR: NONH for all modes of transport
• WGK Germany: WGK 3
• Flash Point(F): 397.4 °F
• Flash Point(C): 203 °C