MOLCAL™ FOL

Calcium Folinate Hydrate

(Calcium supplement)

calcium-folinate-bp
MOLCAL™ FOL commonly known as Calcium Folinate Hydrate, is the calcium salt of folinic acid, a reduced form of folic acid. It is widely used in the pharmaceutical industry as an active pharmaceutical ingredient (API) for folate replacement therapy, methotrexate rescue treatment and in combination with fluorouracil in oncology applications.

MOLCAL™ FOL

by Muby Chem

calcium-folinate

Calcium Folinate Hydrate

Muby Chem operates a state-of-the-art manufacturing facility producing high quality Calcium Folinate Hydrate, known for its exceptional purity and effectiveness. This versatile compound is widely used across various industries including pharmaceutical applications.

Our cutting-edge technology ensures the production of Calcium Folinate Hydrate with exceptional purity and quality, making it an ideal choice for a variety of applications.

Application: MOLCALTM FOL is used as an active pharmaceutical ingredient in pharmaceutical formulations. It is indicated for folate replacement therapy, rescue treatment following high-dose methotrexate therapy, reduction of toxicity associated with folic acid antagonists and as an adjunct to fluorouracil-based chemotherapy regimens. It is used in the manufacture of tablets, capsules, oral solutions and injectable preparations.

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

MOLCAL™ FOL TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 2060570-47-8

SPECIFICATION

#TESTSPECIFICATION - BP
1 Appearance It occurs as white or light yellow, amorphous or crystalline, hygroscopic powder.
2 Identification
Test (A)
Test (B)
Test (C)
Test (D)
(A) Specific optical rotation: + 14.4 to + 18.0 (anhydrous substance).
(B) Infrared absorption spectrophotometry.
(C) Thin-layer chromatography.
(D) It gives reaction (b) of calcium.
3 Solubility It is sparingly soluble in water, practically insoluble in acetone and in ethanol (96%).
4 Appearance of solution Solution S is clear.
5 pH Between 6.8 to 8.0.
6 Specific Optical rotation Between + 14.4 to + 18.0.
7 Absorbance Not more than 0.60.
8 Ethanol Not more than 3.0%.
9 Related substance
(A) Impurity A, E, F
(B) Unspecified impurities
(C) Total
(A) Not more than 0.3%.
(B) Not more than 0.20%.
(C) Not more than 1.5%.
10 Chlorides Not more than 0.5%.
11 Water Between 10.0% to 17.0%.
12 Assay
(A) Calcium Folinate
(B) Calcium
(A) Not less than 97.0% to Not more than 102.0%(anhydrous substance).
(B) Not less than 7.54% to Not more than 8.14% (anhydrous substance).

PACKAGING

MOLCALTM FOL 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. Preserve in well-closed container.

ACCREDITATIONS

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

Disclaimer

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