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医药中间体
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蔗糖铁

详细介绍:



蔗糖铁医药中间体资料简介和所有非肠道铁剂一样,本品会减少口服铁剂的吸收,所以本品不能与口服铁剂同时使用。因此口服铁剂的治疗应在注射完本品的5天之后开始服用。

蔗糖铁的适应症用于正在补充促红细胞生成素的长期血液透析病人缺铁性贫血的治疗。


粉末检验报告

CERTIFICATE OF ANALYSIS

名(Product:

Iron sucrose

CAS NO.:

8047-67-4

号(Batch No.:

1512015

报告日期(Date of Report.):

15/12/19

生产日期(Date of Mfg.:

15/12/17

量(Quantity:

100kg

TEST ITEM

SPECIFICATION

OBSERVATION

Appearance

Brown to dark brown powder

Conforms

Identification A (Iron)

Conform to USP Iron test

Conforms

Identification B (Sucrose)

The retention time of the major peak in HPLC of the assay determination corresponds to that in the chromatogram of the standard determination under assay for sucrose

Conforms

Limit of Iron(II)

NMT 0.4%

0.24%

pH

10.511.1

10.89

Content of Chloride

NMT 0.075%

0.041%

Turbidity (pH)

4.45.3

4.80

Specefic gravity

1.1351.165(20)

1.145

Osmolarity

11501350mOsmol/L

1210mOsmol/L

Alkalinity

0.50.8ml/ml

0.65ml/ml

Mw

3400060000 Da

44300

Mn

NLT  24,000 Da

32000

Mw/Mn

NMT 1.7

1.38

Loss on Drying

NMT 5%

2.0%

Heavy Metal

NMT 25 ppm

Conforms

Arsenic

NMT 4 ppm

Conforms

Assay-Sucrose

NLT 80% (on as is basis)

86.7%

Assay-Iron

5.0%6.0% (on as is basis)

5.50%

结论:本产品均满足所列标准

REMARKS:THE PRODUCT COMPLIES AS PER THE LAID DOWN  SPECIFICATION.

质量负责人:杨威复核者:相杰检验者:孟俊

QA/QC MANAGER          CHECKED BY                  ANALYSED BY



蔗糖铁液体


CERTIFICATE OF ANALYSIS

名(Product:

Iron sucrosesolution

CAS NO.:

8047-67-4

号(Batch No.:

1511029

报告日期(Date of Report.):

15/12/03

生产日期(Date of Mfg.:

15/12/01

量(Quantity:

250kg

TEST ITEM

SPECIFICATION

OBSERVATION

Appearance

Brown - dark  solution

Conforms

Identification A (Iron)

Conform to USP Iron test

Conforms

Identification B (Sucrose)

The retention time of the major peak in HPLC of the assay determination corresponds to that in the chromatogram of the standard determination under assay for sucrose

Conforms

Mw

3400060000 Da

44200

Mn

NLT  24,000 Da

31800

Mw/Mn

NMT 1.7

1.45

PH(2.0% w/v Fe)

9.0-11.1 at  20

10.83

Turbidity (pH)

4.45.3

4.89

Limit of Iron(II)

NMT 0.4%

0.25%

Specefic gravity

1.1351.165(20)

1.147

Osmolarity

11501350mOsmol/L

1200mOsmol/L

Content of Chloride

NMT0.025%0.055%

0.041%

The Ratio of Chloride and Iron

7.014.0mg Cl/g Fe

11.0

Assay-Sucrose

45 %65 %

56.3%

Assay-Iron

3.5%4.0%

3.62%

The Ratio of Sucrose and Iron

13.017.0

15.0

Baterial endotoxin

NMT 3EU/mg Fe

Conforms

Total bacterial

NMT 100CFU/g

Conforms

Total mold/yeast

NMT 10CFU/g

Conforms

EXPIRY DATE :   2017-11-29

结论:本产品均满足所列标准

REMARKS:THE PRODUCT COMPLIES AS PER THE LAID DOWN  SPECIFICATION.

质量负责人:杨威 复核者:相杰检验者:孟俊

QA/QC MANAGER         CHECKED BY                  ANALYSED BY


——完全符合GMP要求!

      ——质量标准符合USP标准!

      ——已成功出口许多国家和地区!




发表日期:2016-3-3  浏览次数:565
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