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GEMCITABINE USP
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DOSAGE FORM: Lyophilized Injection, 200mg/vial, 1gm/vial. 1.4gm/vial.

BIOLOGICAL SIGNIFICANCE

Acts as an effective inhibitor of DNA repair which was specifically demonstrated with regard to DNA damage induced by radiation or alkylating agents. Its potential as a repair inhibitor and its comparatively low toxicity profile make Gemcitabine a promising agent for combination treatments.

CLINICAL USE

Gemcitabine is used in various carcinomas: non-small cell lung cancer, pancreatic cancer, bladder cancer and breast cancer. • It is being investigated for use in oesophageal cancer. • Gemcitabine represents an adv ance in pancreatic cancer care. • Gemcitabine shows benefit in patients with pancreatic cancer who were felt to have successful tumor resections

MODE OF ACTION

Gemcitabine belongs to the family of drugs called antimetabolites. Gemcitabine inhibits thymidylate synthetase, leading to inhibition of DNA synthesis and cell death.

STRUCTURE:

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SPECIFICATIONS
COMPLIES TO USP
PARAMETER LIMIT
ASSAY NLT 95% AND NMT 105%
BACTERIAL ENDOTOXIN NMT 0.05 USP ENDOTOXIN UNITS PER MG OF GEMCITABINE
PH 2.7 – 3.3
STERILITY SHOULD COMPLY USP
PARTICULATE MATTER SHOULD COMPLY TO USP
   
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