Qhov loj 00 Zaub HPMC Ntsiav Tshuaj Ntsig TDS

Jul 14, 2020

Tso lus

	Cov Ntaub Ntawv Cov Ntawv

Khoom	Hydroxypropyl methyl cellulose raws tshuaj ntsiav

Qib	HPMC-Caps # 00-T

Qhov Coob	#00

Lub cev xim	Pob tshab

Cap xim	Pob tshab

Muaj pes tsawg leeg	Hypromellose, Excipients, Dej

EEC Nr.	E464, E418

Cov chaw muag tshuaj	EP / USP-NF / FCC

Cov yam ntxwv
Yam khoom	Chav Nyob	Specification

Nyhav	mg	123.0 ±8.0

Tshuaj ntsiav ntev (kaw)	hli	23.4 ±0.5

Lub cev ntev	hli	20.05 ±0.4

Cap ntev	hli	11.80 ±0.4

Txoj kab uas hla sab nraud	hli	Lub cev: 8.15-8.25	Cap: 8.50-8.60

Phab Ntsa Thickness	hli	Lub cev: 0.110 ± 0.02	Cap: 0.115 ± 0.02

Ntim	ml	0.93

Cov lus qhia tshwj xeeb (sim qauv: TS.QC.C01)
Yam khoom	Chav Nyob

Disintegration lub sijhawm	Feeb	Max. 15 15

Cov roj ntsiab lus	%	Max. 0.5

Poob rau kom qhuav	%	Max. 8,5

Cov ntsiab lus seem	%	Max. 3

Cov hlau hnyav	%	Max. 0.001

Arsenic	%	Max. 0.0002

Tag nrho cov kab mob suav	cfu / g	Max. 1000

Tag nrho cov poov xab thiab pwm suav	cfu / g	Max. 100

Escherichia coli		Tsis pom

Dab Tsi Staphylococcus aureus		Tsis pom

COA qauv ntawm Zaub HPMC Empty Capsule loj 0

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