这是用户在 2024-8-28 14:51 为 https://app.immersivetranslate.com/pdf-pro/b1c8b167-650b-48d4-8a2c-8c42b42129ac 保存的双语快照页面,由 沉浸式翻译 提供双语支持。了解如何保存?
2024_08_28_1dc4282360609797d503g
Costar Pharmaceutical Laboratory Pty Ltd.
RECORD FM 063 调频 063 Page 1 of 2 第 1 页 共 2 页
Subject: 主题: Certificate of Analysis 分析证书 Version No: 3 版本号: 3
Date Effective:
生效日期:
Product Name: Colostrum 45mg IgG tablet
产品名 : 牛初乳 45mg IgG 片剂
Product Code: 23 产品编号: 23 Batch Number: CS24173 批号:CS24173 ARTG Number: N/A ARTG 编号: N/A
Manufacturing Date:05/2024
制造日期:05/2024
Expiry Date:  有效期: QTY: 392,300 数量: 392,300
Test: 测试: Specification 规范 Result 结果
Physical 物理的
Description 描述 13 minim cream coloured round flat faced tablet
13 Minim 奶油色圆形平面片剂
Complies 符合
Dosage Form 剂型 Uncoated tablet 无包衣片剂 Complies 符合
Average Weight 平均重量 820.00 mg (Range:
820.00 毫克(范围:
834.30 mg 834.30 毫克
Uniformity of Weight 重量均匀性

20 片单片中不超过 2 片与平均重量的偏差, 20 片中不超过 20 片的偏差超过
No more than 2 out of 20 of the individual tablets
deviate from the average weight by more than
and none out of 20 tablets deviate by more than
Complies 符合
Disintegration 瓦解 NMT30 min NMT30 分钟
 12 分钟,符合
12 minutes,
complies
Chemical 化学的 Label claim 标签声明 Limit 限制
Immunoglobulin G 免疫球蛋白 G 45mg/tablet 45毫克/片 Complies+ 合规+
Microbiological 微生物
Total Aerobic Microbial Count
总需氧微生物计数
NMT 10000 cfu/g Part of rotation^ 旋转的一部分^
Total Yeast and Mould Count
酵母菌和霉菌总数
NMT Part of rotation^ 旋转的一部分^
Bio-tolerant Gram Negative Bacterial
生物耐受革兰氏阴性菌
NMT Part of rotation^ 旋转的一部分^
E. coli 大肠杆菌 Not detected/g 未检出/g Part of rotation^ 旋转的一部分^
S. aureus 金黄色葡萄球菌 Not detected/g 未检出/g Part of rotation^ 旋转的一部分^
Salmonella 沙门氏菌 Not detected  未检测到 Part of rotation^ 旋转的一部分^
Elemental Impurities 元素杂质
Lead (Pb) 铅 (Pb) NMT Part of rotation^ 旋转的一部分^
Cadmium (Cd) 镉 (Cd) NMT Part of rotation^ 旋转的一部分^
Arsenic (Inorganic) 砷 (Inorganic) NMT Part of rotation^ 旋转的一部分^
Mercury (Total) 汞 (总计) NMT Part of rotation^ 旋转的一部分^
Methylmercury (as Hg) 甲基汞(以 Hg 计) NMT Part of rotation^ 旋转的一部分^

备注 + : 未进行化验。按输入 量量化 :轮换程序的一部分,此批次未进行测试
Remarks
+ : Not Assayed. Quantified by Input
: Part of rotation program, this batch was not tested

残留溶剂:由于我们在原材料测试和审批过程中评估了残留溶剂,因此不需要对成品进行溶剂测试。制造过程不包括任何残留溶剂的添加。
Residual solvent: No solvent testing is required in finished product as we assessed the residual solvent on raw
material testing and approval process. Manufacturing process does not include any addition of residual solvent.
Costar Pharmaceutical Laboratory Pty Ltd.
RECORD FM 063 调频 063 Page 2 of 2 第 2 页,共 2 页
Subject: 主题: Certificate of Analysis 分析证书 Version No: 3 版本号: 3
Date Effective: 16/02/2023
生效日期: 16/02/2023

Release for supply statement
供应下达声明

This is to certify that batch documentation, testing records of bulk, finished product and stability of the product have been checked and found to be in compliance with the master documentation (i.e. marketing authorisation and/or specifications) and conformity to cGMP. Explanations for any deviations from the approved process, if any, are authorised and explained. This batch has been approved for
这是为了证明批次文件、散装、成品和产品稳定性的测试记录已经过检查,并发现符合主文件(即上市许可和/或规格)并符合 cGMP。对与批准流程的任何偏差(如有)的解释均已获得授权并予以解释。此批次已获批
  • Released for Further Processing
    发布以供进一步处理
OR 
  • Released for Supply 已下达供应
TGA licence Number: MI-2014-LI-01856-1
TGA 许可证号:MI-2014-LI-01856-1
Signed:  签署:

(QA Manager/ Delegate) (QA 经理/代表)