MOLACID® CITM

Citric Acid (Monohydrate)

(Preservative / Buffering Agent / Flavor Enhancer)

citric-acid-monohydrate-ip
MOLACID® CITM is an organic acid extensively used in pharmaceutical applications as a pH adjuster, buffering agent and preservative. It plays a crucial role in enhancing the stability and solubility of drug formulations, especially in oral solid dosage forms such as tablets, by maintaining an optimal microenvironmental pH and improving the dissolution profile of active pharmaceutical ingredients.

MOLACID® CITM

by Muby Chem

citric-acid-monohydrate-i

Citric Acid (Monohydrate)

Muby Chem operates a state-of-the-art manufacturing facility producing Citric Acid (Monohydrate) known for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our cutting-edge technology guarantees uniformity and consistency in the production of Citric Acid (Monohydrate) optimizing its performance as both a preservative and buffering agent.

Applications: MOLACID® CITM is widely used in pharmaceutical formulations to adjust pH, stabilize active ingredients and enhance solubility. It also improves microbial stability, frequently used in combination with other preservatives. It enhances taste by masking the bitterness of certain drugs.

We follow Good Manufacturing Practices (GMP) and adhere to international regulatory standards to ensure quality consistency with continuous supply.

MOLACID® CITM TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS Number 5949-29-1
2 Molecular Formula C6H8O7.H2O
3 Molecular Weight 210.1 g/mol

SPECIFICATION

#TESTSPECIFICATION - IP
1 Description It occurs as colourless crystals or a white, crystalline powder; slightly efflorescent in warm, dry air.
2 Identification
Test (A)

Test (B)
Test (C)
(A) Compare the spectrum with that obtained with citric acid monohydrate IPRS or with the reference spectrum of citric acid monohydrate.
(B) It gives reaction of citrates.
(C) A 10.0% w/v solution is strongly acidic.
3 Appearance of solution The solution is clear, and not more intensely colored than reference solution YS7, BYS7. or GYS7.
4 Arsenic Not more than 1 ppm.
5 Barium Any opalescence produced is not more intense than that of a mixture of 5 ml of solution A and 5ml distilled water.
6 Heavy Metal Not more than 10 ppm.
7 Iron Not more than 50 ppm.
8 Chlorides Not more than 50 ppm.
9 Sulphates Not more than 150 ppm.
10 Oxalic acid Any pink color produced is not more intense than that produced by carrying out the test using 0.2 mg of oxalic acid dissolved in 4 ml of water.
11 Readily carbonisable substances Any colour produced is not more intense than that of a mixture of 1.0 ml of CCS and 9.0 ml of FCS.
12 Sulphated Ash Not more than 0.1%.
13 Water Between 7.5% to 9.0%.
14 Assay Not less than 99.5% to not more than 100.5% (anhydrous substance).

PACKAGING

MOLACID® CITM is packed in HDPE bag or HDPE drum with double PE liners inside and is provided with a barcoded label and a tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in tight containers.

ACCREDITATIONS

fda
health canada
edqm1
edqm
sgs
ANVISA
sfda
saphra
tga
china
mhra
cdsco
who
eu
exci
ecovadis

Disclaimer

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