MOLCIT® CAF

Caffein citrate

(CNS Stimulant / Pharmaceutical Active Ingredient)

caffein-citrate-caf-ih
MOLCIT® CAF is an organic compound, commonly known as Caffein citrate. It is a pharmaceutical active ingredient with central nervous system stimulant activity. After administration, caffeine is released and acts primarily by blocking adenosine receptors, helping increase alertness and stimulate respiratory activity.

MOLCIT® CAF

by Muby Chem

caffein-citrate-caf

Caffein citrate

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

Our advanced technology ensures the production of high-quality Caffein citrate meeting the highest standards for performance and consistency.

Application: MOLCIT® CAF is used as a pharmaceutical active ingredient in suitable oral and injectable formulations. It is particularly used in neonatal formulations for the management of apnea of prematurity, where caffeine stimulates the central nervous system and respiratory drive. It may be formulated as oral solutions, oral liquids, tablets or injectable preparations, depending on the approved product and application.

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

SPECIFICATION

#TESTSPECIFICATION - IH
1 Appearance It occurs as white crystalline powder.
2 Identification
Test (A)


Test (B): Citrate
(A)The principal peak in the chromatogram obtained with the test solution corresponds to the principal peak in the chromatogram obtained with reference solution (a).
(B) Produces a violet colour, turning to violet-blue.
3 Solubility It is soluble in water.
4 Heavy metal Less than 15 ppm.
5 Radially carbonisable Substances Any colour produced is not more intense than that of a mixture of 1.0 ml of CCS and 9.0mI of FCS.
6 Sulphated Ash Not more than 0.1%.
7 LOD at 105°C for 3 h Not more than 5.0%.
8 Assay
(A) Anhydrous Caffeine content
(B) Anhydrous Citric acid
(C) Sum total of above percentage
(A) Not less than 48.0% and not more than 52.0% w/w.
(B) Not less than 48.0% and not more than 52.0%w/w.
(C) Not less than 98.5% and not more than 101.0% w/w.

PACKAGING

MOLCIT® CAF is packed in HDPE bag or HDPE drum Packing 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 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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