Amlodipine Granules

Amlodipine Granules
CAS No. 88150-42-9
Pharmacopia: Inhouse
CAS No. 88150-42-9

Enhanced Uniformity at low dose

Tailored solution to offer advantage over below;

  • High volume
  • Hydrolysis, Oxidation and Photo-degradation
  • Low dose – BU and CU is critical
  • Process Complexities (multi-step)
  • Lengthy production time
  • Multiple analysis of RM and in-process
Product% Drug conc.API PharmacopoeiaLubricated / Non lubricatedLabel claimTablet weight
Amlodipine Granules10.10%IPNon-LubricatedEach 49.5 mg of Non-Lubricated granules contains Amlodipine besylate equivalent to Amlodipine 5 mgAny weight higher than 49.50 mg
10.00%IP/EPLubricatedEach 50 mg of Lubricated granules contains Amlodipine besylate equivalent to Amlodipine 5 mg50 mg (core tablet)
7.70%IPLubricatedEach 65 mg of Lubricated granules contains Amlodipine besylate equivalent to Amlodipine 5 mg65 mg (core tablet)
6.94%EPNon-LubricatedEach 72 mg of Lubricated granules contains Amlodipine 5 mg72 mg
3.47%EPLubricatedEach 144 mg of Lubricated granules contains Amlodipine 5 mg210 mg (core tablet)
2.40%IPNon-LubricatedEach 208.33 mg of Non-Lubricated granules contains Amlodipine besylate equivalent to Amlodipine 5 mgAny weight higher than 49.50 mg
2.38%IPLubricatedEach 210 mg of Lubricated granules contains Amlodipine besylate equivalent to Amlodipine 5 mg210 mg (core tablet)
SpecificationDetails
PSD90% of particles are less than 250 micron (ASTM 60 passed)(PSD can be customized based on customer requirements)
PharmacopoeiaIH Specification
Shelf life2 years re-test
Pack size (MOQ)5 kg, 10 kg, 20 kg
Batch sizeUp to 500 kgs
Lead time45 to 60 days (will be confirmed at the time of purchase order)

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