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文件编号：XXX版本号：XXX股份有限公司
X PHARMACEUTICAL CO., LTD
产品出厂检验报告单(Certificate Of Analysis)
sgs报告
□々
口口骨：
D-氨基葡萄糖盐酸盐
Product Name:
D-GLUCOSAMINE HYDROCHLORIDE
生产批号：
报告日期：
Batch No.：
Report Date ：
生产日期：
Manufacture Date ：
数量：
有效期：
Batch Size：
Expire Date:
检验项目
Items
规格 Specification
结果 Results
Infrared Absorption
鉴另IJ
Identification
Chloride
Conformed
HPLC
外观
Appearance
A white crystalline powder
Conformed
比旋度
Specific rotation[a]20D
+70.0°—+73.0°
+72.42°
含量
Content
98.0%—102.0%
100.0%
硫酸盐
Sulfates
<0.24%
<0.24%
干燥失重
Loss on drying
<0.5%
0.07%
炽灼残渣
Residue on ignition
<0.1%
0.08%
酸碱度
pH
3.5—5.0
4.29
氯化物
Chloride
16.2%—16.7%
16.5%
堆积密度
Bulk density
Meets the requirements
0.75g/ml
拍击密度
Tapped density
Meets the requirements
0.97g/ml
目 数
Mesh Size
Meets the requirements
100%through 30 mesh
珅
Arsenic
<3 ppm
<3ppm
总细菌数
Total plate count
<1000cfu/g
20cfu/g
霉菌和酵母菌数
Yeast&Mold
<100cfu/g
1 Ocfu/g
大肠杆菌
E.COLI
Negative/g
Negative/g
沙门氏菌
Salmonella
Negative/10g
Negative/10g
金黄葡萄球菌Staphylococcus Aureus
Negative/g
Negative/g
储仔条件
Storage Conditions
Preserve in tight, light-resistant containers.
结 论
Conclusion
Conforms to USP39
注：按照ICHQ3D的相关要求，针对不是有意添加元素杂质的口服产品应考虑的杂质包括镐Cd、铅Pb、碑As、汞Hg、钻Co、
凯V、镣Ni。将连续3批成品批次委托SGS检测这些兀素杂质和铭Cr,低于30%口服浓度限度，可以不用采取额外的措施（如：
建立其在产品中的规格限度），产品能够符合ICH Q3D元素杂质的限度要求。
Note： According to ICH Q3D, the elemental impurities of the oral product which the impurities are not intentionally addedshould be
considered including Cd, Pb, As, Hg, Co, V, Ni,
These elemental impurities and another element impurity Cr of 3 representative
production scale lots of the product were tested by SGS and consistently less than 30%of the oral concentration, which demonstrate
additional controls (e.g.establishment of the specification limits for the product) are not required.The elemental impurities of the
product conform the requirement of ICH Q3D.
报告人（QC）/R叩orter：核人（QC 经理）/Rechecked by:批堆准入（QA 经理）/ Approver:
地址：
Add:N： TEL: 传真：Fax：