MOLCAL™ FOL

Calcium Folinate Hydrate

(Calcium Supplement)

Calcium Folinate Hydrate
MOLCAL™ FOL is commonly known as Calcium Folinate. It is the calcium salt of folinic acid, a reduced form of folic acid. MOLCAL™ FOL 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 Hydrate Product

Calcium Folinate Hydrate

Muby Chem operates a state-of-the-art manufacturing facility that produces Calcium Folinate Hydrate renowned for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our advanced technology ensures the production of Calcium Folinate Hydrate with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.

Application: MOLCAL™ 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. MOLCAL™ FOL 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 Number 2060570-47-8

SPECIFICATION

#TESTSPECIFICATION - EP
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.
(B) Infrared absorption spectrophotometry.
(C) Thin-layer chromatography.
(D) It gives reaction of calcium.
3 Solubility It is sparingly soluble in water, practically insoluble in acetone and in ethanol 96%.
4 Appearance of solution. Solution is clear.
5 PH Between 6.8 to 8.0.
6 Specific optical rotation Between +14.4 to +18.0 (anhydrous substance).
7 Absorbance Not more than 0.60.
8 Ethanol Not more than 3.0%.
9 Related substances.
(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 10.0% to 17.0%.
12 Assay
(A) Calcium folinate
(B) Calcium
(A) Not less than 97.0% and not more than 102.0%.
(B) Not less than7.54% to not more than 8.14%.

PACKAGING

MOLCAL™ 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 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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