焦作中维特品药业股份有限公司

Jiaozuo Zhongwei Special Products Pharmaceutical

Co., Ltd.
检 验 报 告 地址：河南省温县工业集聚区鑫源路东段 115 号
Add: No.115, East Xinyuan Road, Wen Town, 454800, Henan,
China.
Tel: 0391-6109928
CERTIFICATE OF ANALYSIS
Fax: 0391-6109918
品名/PRODUCT： PVP K30 规格/SPECIFICATION： PHARMA GRADE
批号/LOT NO.： 2212010 数量/AMOUNT ： 500GS
生产日期/MFG. DATE： 2022-12-10 有效期/EXPIRY DATE： 2025-12-09

测定项目 指 标 实测值
TEST ITEMS SPECIFICATION TEST VALUE
K 值/K value 27-32 31.1
水份/Moisture % ≤5.0 3.14
PH 值(5%水溶液)/PH Value(5% in water) 3.0-5.0 3.54
N-乙烯基吡咯烷酮/NVP ppm ≤10 1.8
炽灼残值/Residue on ignition % ≤0.1 0.05
氮含量/Nitrogen % 11.5-12.8 12.1
醛（以乙醛计）/Aldehydes(as acetaldehyde) ppm ≤500 210
重金属（以铅计）/Heavy metals(as Pb) ppm ≤10 <10
肼/Hydrazine ppm ≤1.0 <1.0
过氧化物/Peroxides( as H2O2) ppm ≤400 166
2-吡咯烷酮/2-Pyrrolidone % ≤3 1.5
甲酸/Formic acid % ≤0.5 0.35
细菌总数/ Total Aerobic plate count CFU/g ≤100 <100
葡萄状球菌/ Staphylococcus Aureus, CFU/g 不得检出/Negative Negative
沙门氏菌/ Salmonella, CFU/g 不得检出/Negative Negative
假单胞菌/ Pseudomonas aeruginosa, CFU/g 不得检出/Negative Negative
大肠杆菌/ E.coli CFU/g 不得检出/Negative Negative
易溶于水、96%的酒精和甲醇，
微溶于丙酮
Freely soluble in water, in
溶解性/Solubility Conform
ethanol(96 percent) and in
methanol very slightly
soluble in acetone
白色或乳白色粉末
外观/Appearance White or yellowish-white White powder
powder
无色或浅黄色液体 colorless or
溶液外观/Solubility Conform
yellowish-white solution
 A. 红外图谱对照
IR spectrum obtained is
Conform
consistent with
that abtained with Povidone
CRS.
B. 生 成 橙 黄 色 沉 淀 An Conform
orange-yellow precipitate is
鉴别 Identification
formed.
C. 生 成 浅 蓝 色 沉 淀 An pale
Conform
blue precipitate is formed.
D. 显 红 色 A red colour is
Conform
produced.
E. 易 溶 解 The substance
Conform
dissolves
贮藏条件/Storage Conditions : Keep in dry place, store in tight closed container.

分析者意见/OPINION OF THE ANALYSER

本样品符合/THIS PRODUCT MEETS THE REQUIREMENTS FOR

■药用级标准 USP44

分析人：
ANALYSER：03