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FAHRENHETT
PT. PRATAPA NIRMALA

CERTIFICATE OF ANALYSIS
WORKING STANDARD

Certificate No. WS.RDPN/OI8/VIIYIS

Product Rosuvastatin calcium
Batch No. 24t0900rt7
QCNo. 0r0-cP-01
Analysi s date/Retest date February O2h, 2Ol8 I Jwe, 2019

Reference to Rosuvastatin calcium CRS, Lot :batchZ

Note From Vendor : Teva API India
Working standar No. BS-R02.02

No Test Specification Result

l. Description White or almost white, hygroscopic powder. White, hygroscopic

powder

) Identification IR spectrum should be concordant with Conform

working standard spectrum of sample, .(Correlation
: 0,9322)
correlation > 0.90

-r- Water content Not more lhut6,l o/o 1,85 yo

4, Assay 97,0 o - 102,0 %o of Rosuvastatin calcium, 99,95 0

calculated on anhydrous basis

Conclusion : Thtr product complies with the above specification.

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ErfnarretiH, P B4I4 PA N l RIvl.A L A

R&D Manager

Office : Jl. Raden Saleh Raya No. 4, Jakarta 10430, Phone : +62 2139030903 (Hunting) Fax. '. +6221 3903090
Factory : Jl. Industri VI, Tangerang 15 135, Indonesia, Phone : +62 21 590187 5-77 Fax. ; +62 21 5901984