China Chymotrypsin nke Deebio maka ịgwọ ọnya nke ụlọ ọrụ na-emepụta ihe na-emepụta ihe na-emepụta ihe |Deebiotech

Chymotrypsin nke Deebio maka ịgwọ ọnya nke edema na-efe efe

CAS NO.:9004-07-3

Koodu HS:3507.9090.90

Ọrụ faịlụ:DMF

Ọkọlọtọ Pharmacopoeia:EP/USP

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Nkọwa ngwaahịa

Mkpado ngwaahịa

Nkọwa

1. Characters: White ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ọcha kristal ntụ ntụ, enweghị isi, hygroscopic.

2. Isi mmalite: Porcine pancreas.

3. Usoro: A na-ewepụta Chymotrypsin site na pancreas nke porcine dị mma ma kwadebere ya site na usoro pụrụ iche.

4. Ngosipụta na ojiji: Proteolytic enzyme.Ọ nwere ike ịkwalite liquefaction nke mkpụkọ ọbara, purulent secretions na necrotic anụ ahụ.A na-eji ya na-agwọ ọnya nke edema na-egbuke egbuke, mkpali adhesion, hematoma, ọnya.Chymotrypsin sitere na bovine pancreas ka ejiri mee nchọpụta iji nyochaa mmịpụta protein site na sistemu microemulsion Winsor-III.α-Chymotrypsin sitere na pancreas ka ejirikwa ya mee nyocha iji nyochaa nyocha fluorescent ọhụrụ akọwapụtara nke ọma maka trypsin.

Gịnị mere anyị?

· P0 emepụtara na ụlọ ọrụ GMP

· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D

· A na-achọpụta ihe ọkụkụ

Soro EP, USP na ọkọlọtọ ndị ahịa

· Ọrụ dị elu, ịdị ọcha dị elu, nkwụsi ike dị elu

· Mbupụ gaa na mba na mpaghara iri atọ

· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.

Nkọwapụta

Nnwale ihe		Nkọwapụta ụlọ ọrụ
Nnwale ihe		EP	USP
Ndị agwa		kristal ọcha ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ntụ ntụ ọcha, enweghị isi, hygroscopic	Ọcha ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ọcha na-ehichapụ ntụ ntụ
njirimara		Dabara	Dabara
Nnwale	Histamine	≤ 1ug (ọrụ Chymotrypsin / 5mk)	————
	Ido anya	Dabara	Dabara
	pH	3.0～5.0	————
	Mmanya	A₂₈₁:18.5～22.5,A₂₅₀≤ 8	————
	Trypsin	Dabara	≤ 1.0%
	Ọnwụ na ihicha	≤5.0%	≤ 5.0% (60 ℃ Mbelata 4h)
	Ihe fọdụrụ na mgbanye	————	≤2.5%
Ihe omume		≥ 5.0mk/mg	≥ 1000USP.U/mg (ihe akọrọ)
Microbial adịghị ọcha	TAMC	≤1000cfu/g	≤1000cfu/g
	TYMC	≤100cfu/g	≤100cfu/g
	E.coli	Dabara	Dabara
	Salmonella	Dabara	Dabara
	Staphylococcus aureus	————	Dabara
	Pseudomonas aeruginosa	————	Dabara