MONTHLY STABILITY UPDATE

Stability Department, Formulation & Research Facility, Lalru.

Updates for the Month of: December Issuance Date: January 9, 2012 Update No.: 10/12

1.0

FORMULATION RESEARCH & DEVELOPMENT: Batch No./ Pack/Condition Stability Update 1418/080, 1418/084, Assay decreased to about 88% at 30/65 and about 94% at 25/60 1418/088-6M [Initial about 99%]. Impurities are 2-5% at 30/65 and about 0.9% at 25/60 [Limit NMT 1%] 1536/054, 1536/058-3M Samples are failing in impurity at RRT 0.3. 40/75 o 1536/054: Impurity is 1.4% o 1536/058: Impurity is 0.9% [Limit NMT 0.75%] o Results are within limits at 30/65-3M. DIPARD1101 Initial Sample is failing in Content Uniformity for Diclofenac [87106%, Mean 96.6%, L1: 17.1, Limit L1 NMT 15]

Product Cycloserine Capsule

Glizid MR 60 Tablets

Diclofenac and Paracetamol Tablets 2.0

ADVANCE DRUG DELIVERY RESEARCH: 1580/070-40/75-1M

Paracetamol Tramadol Tablets 3.0

Des Methyl tramadol impurity increased to 0.49% [Limit NMT 0.2%]

STUDIES INITIATED LAST MONTH: *No. of Batches 13 1 10 1 3 1 2 1 1 3 1

Product Name Prasugrel tablets Diclofenac Paracetamol tablets Acetaminophen Tramadol Tablets Darifenacin ER Tablets Sevelamer Carbonate Film Coated Acetaminophen ER tablets Sevelamer Carbonate DT Mycophenolate MR Tablets Mecobalamine Injection Glimperide Metformin SR tablets Colesevelam HCL Film coated tablets
*One batch packed in different pack is considered as different batch.

4.0

STUDIES INITIATED WITHOUT STP:

Voriconazole IR Tablets Sevelamer Carbonate tablets film coated Colesevelam HCL Film coated tablets Acetaminophen ER tablets

Compiled By: Sanjiv Kumar Sharma, Formulation & Research Facility, Lalru.

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This update contains details about the products loaded on stability, which has shown some degradation/ change in any of the parameter under study.