MOLACID® CITA

Citric Acid (Anhydrous)

(Chelating Agent / pH Stabilizer)

citric-acid-anhydrous-ip
MOLACID® CITA is an organic compound widely recognized as Citric Acid (Anhydrous). It is extensively used in ophthalmic preparations, particularly in artificial tears and eye irrigating solutions, due to its role in maintaining pH balance and stabilizing formulations.

MOLACID® CITA

by Muby Chem

citric-acid-anhydrous-i

Citric Acid (Anhydrous)

Muby Chem operates a state-of-the-art manufacturing facility producing Citric Acid (Anhydrous) 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 (Anhydrous) ensuring optimal pH balance, enhanced formulation stability and improved compatibility in ophthalmic solutions such as artificial tears and eye irrigating products

Application: MOLACID® CITA functions as a pH stabilizer and chelating agent, maintaining the appropriate pH to reduce eye irritation while enhancing the stability and effectiveness of active ingredients in ophthalmic and other pharmaceutical formulations.

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

MOLACID® CITA TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 Molecular Formula C6H8O7
2 Molecular Weight 192.1 g/mol

SPECIFICATION

#TESTSPECIFICATION - IP
1 Description It occurs as colourless crystals or a white powder; slightly hygroscopic in moist air.
2 Identification
Test (A)

Test (B)
Test (C)
(A) Compare the spectrum with that obtained with citric acid IPRS or with the reference spectrum of citric acid.
(B) It gives reaction of citrates.
(C) A 10% 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 produce is not more intense than that of a mixture of 5 ml of solution A and 5 ml of 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 colour 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 Not more than 1.0%.
14 Assay Not less than 99.0% and not more than 101.0% of C6H8O7 (anhydrous basis).

PACKAGING

MOLACID® CITA is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserved in well-closed container.

ACCREDITATIONS

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

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