Umkhiqizo

Into

Ukucaciswa

Into

Ukucaciswa

Ukubukeka

I-crystalline powder emhlophe noma emhlophe

Ukuzungezisa okuqondile

-28.0°~-34.0°

Ifomu le-Crystal

Kufanele ibe crystalline Ⅰ, ibe nama-engeli angu-2-theta we

14.4±0.2°,19.2±0.2°,21.7±0.2°,24.3±0.2°29.3±0.2°

Ukuhlonza

IR, HPLC

Izinto ezihlobene I

PO-R1 NMT 0.10%

PO-R2 NMT 0.10%

PO-R3 NMT 0.10%

PO-R4 NMT 0.10%

I-PO-D3 ne-PO-D5 NMT 0.10%

I-PO-D7 & PO-D10 NMT 0.10%

Ukungcola ngakunye okungashiwongo kwe-NMT 0.10%

Ukungcola okuphelele kwe-NMT 0.5%

Izinto ezihlobene Ⅱ

I-PO-E NMT 0.10%

I-PO-D1 NMT 0.10%

PO-R5 NMT 0.10%

Izincibilikisi ezisele

I-Methanol NMT 3000ppm

I-Ethanol NMT 5000ppm

I-Dichloromethane NMT 600ppm

I-Tetrahydrofuran NMT 720ppm

N, N-dimethyl formamide NMT 880ppm

I-Triethylamine NMT 100ppm

I-Dimethy sulfoxide NMT 5000ppm

Amanzi

I-NMT 2.0%

Izinsalela ekushiseni

I-NMT 0.1%

Izinsimbi ezinzima

I-NMT 10ppm

Umkhawulo we-Microbial

Isamba se-aerobic NMT 1000cfu/g

Isamba semvubelo nezibunzi ze-NMT 100cfu/g

I-E.coli kufanele ingabi khona

Isivivinyo

98.0% -102.0%(kwisisekelo se-anhydrous)

98.0% -102.0%(kusisekelo samahhala se-anhydrous kanye nezincibilikisi)