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Product Information
Product name
Dinoprost Trometamol
Dinoprost Tromethamine
Prostaglandin F2a tris salt
CAS No.
38562-01-5
Molecular Formula
C24H45NO8
Molecular Weight
475.6
Quality Standard
97% up, Medicine Grade
Appearance
White to off-white powder
COA of Dinoprost Trometamol
TEST
SPECIFICATION
RESULTS
Appearance
White to off-white powder
Off-white powder
Specific rotation
+19。- +26。
+24.0。
Loss on drying
≤ 1.0%
0.16%
Residue on ignition
≤0.5%
0.01%
Identification
IR
The IR spectrum of the sample exhibits maximum only at the same wavelength as that a similar preparation of USP Dinoprost Tromethamine RS
Conform
Related substances
Impurity A
Impurity C
Any unspecified impurity
Total impurities
≤ 2.0%
≤ 1.5%
≤ 0.5%
≤ 2.0%
0.76%
Not detected
0.35%
0.44%
Residual Solvents
Methanol
Ethanol
Acetontrile
Acetone
Ethyl acetate
Tetrahydrofuran
≤ 3000ppm
≤ 5000ppm
≤ 410ppm
≤ 5000ppm
≤ 5000ppm
≤ 720ppm
Not detected
Not detected
Not detected
621 ppm
Not detected
Not detected
Assay
95.0%-105.0% (on the dried basis)
97.6%
Conclusion
Complies with the USP and in-house standards
Usage
Function of Dinoprost Tromethamine
Dinoprost Tromethamine is a synthetic analogue of the naturally occurring prostaglandin F2 alpha. Prostaglandin F2 alpha stimulates myometrial activity, relaxes the cervix, inhibits corpus luteal steroidogenesis, and induces luteolysis by direct action on the corpus luteum.
Application of Dinoprost Tromethamine
Estrus synchronization, induction of parturition; Treatment of persistent corpus luteum, induction of delivery and expulsion of stillbirth; Treatment of endometriosis.
Twenty years of qualification
Audited Supplier
Pharma Sources Insight June 2024: Globalization on the Go
