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Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-cortisol [50-23-7]


质量标准: 

美国药典25版 

鉴别:符合规定 

A: 红外吸收 

B: 紫外吸收 

比旋度:+150°~ +156° 

干燥失重 ≤ 1.0 % 

灼烧残渣:可以忽略 

层析杂质: 

单个杂质≤0.5% 

总杂质≤2.0% 

有机挥发杂质: 符合要求 

含量: 97%~102% 

Quality standard:

USP25

Identification: 

A: Infrared Absorption 

B: Ultraviolet Absorption

Specific rotation :between +150°and +156°

Loss on drying:≤ 1.0 % 

Residue on ignition: negligible from 100mg 

Chromatographic Purity: 

Individual purity≤0.5% 

Total purity≤2.0% 

Organic volatile impurities: meets the requirements 

Assay: 97%~102%


氢化可的松
氢化可的松

Pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)-

Cortisol 21-acetate [50-03-3]


质量标准: 

美国药典25版 

鉴别:符合规定 

A: 红外吸收 

B: 紫外吸收 

比旋度:+158°~ +165° 

干燥失重 ≤ 1.0 % 

灼烧残渣:可以忽略 

层析杂质: 

单个杂质≤1.0% 

总杂质≤2.0% 

含量: 97%~102% 

Quality standard:

USP25

Identification:

A: Infrared Absorption

B: Ultraviolet Absorption

Specific rotation :between +158°and +165°

Loss on drying:≤ 1.0 %

Residue on ignition: negligible from 100mg

Chromatographic Purity:

Individual purity≤1.0%

Total purity≤2.0% 

Assay: 97%~102%


醋酸氢化可的松
醋酸氢化可的松

C22H24N2O8·HCl·1/2C2H6O·1/2H2O 512.9 [24390-14-5]


质量标准: 

英国药典2000版 

性状:黄色结晶粉末 

PH值:2.0~3.0 

比旋度:-105°~ -120° 

吸光率:349nm下300~335 

杂质光吸收:490nm下≤0.07 

相关杂质: 

乙醇:4.3~6.0 

重金属:≤50ppm 

水分:1.4%~2.8% 

硫酸盐灰烬:≤0.4% 

细菌内毒素:≤1.14 I.U./mg 


Quality standard:

BP2000

Characters: A yellow crystalline powder

PH: 2.0~3.0

Specific optical rotation : -105°~ -120°

Absorbance: 300~335@349nm

Light-absorbing impurities: ≤0.07@490nm

Related substances

Ethanol: 4.3~6.0

Heavy metals: ≤50ppm

Water: 1.4%~2.8%

Sulphated ash: ≤0.4%

Bacterial endotoxins: ≤1.14 I.U./mg


强力霉素
强力霉素

4-(Dimethylamino)-1,4,4a,5,5a, 6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy

-6- methlene- 1, 11 -dioxo- 2 - naphthacennecarboxamide monohydrochoride. [3963-95-9]


质量标准: 

英国药典2000版


鉴别:紫外吸收 

结晶度:符合要求 

PH值:2.0~3.0 

水分:≤ 2.0% 

效价:每毫克效价=832~970μg土霉素


Quality standard:

BP2000

Identification: Ultraviolet Absorption

Crystallinity: meets the requirements

PH: 2.0~3.0

Water: ≤ 2.0%

Potency: equivalent to 832~970μg Methacycline per mg


盐酸甲烯土霉素
盐酸甲烯土霉素

18,19-Dinorpregn-4-en-20-yn-3-one,13-ethyl-17-hydroxy-,(17α)-(-)-(-)-13-

Ethyl-17-hydroxy-18,19-dinoxr-17α-pregn-4-en-20-yn-3-one [797-63-7]


质量标准: 

美国药典25版 

鉴别:符合规定 

A: 红外吸收 

熔程:232℃~ 239℃ 

比旋度:-30°~ -35° 

干燥失重 ≤ 0.5 % 

灼烧残渣:≤0.3% 

乙炔化合物限度:7.81%~8.18% 

层析杂质: 

单个杂质≤0.5% 

总杂质≤2.0% 

含量: 98%~102%


Quality standard:

USP25

Identification:

A: Infrared Absorption

Melting range: 232℃~ 239℃

Specific rotation: between -30°and -35°

Loss on drying:≤0.5 %

Residue on ignition:≤0.3% 

Limit of ethynyl group: 7.81%~8.18%

Chromatographic purity:

Single impurity≤0.5%

Sum of impurities≤2.0% 

Assay: 98%~102%


左炔诺孕酮
左炔诺孕酮

3,5-pyrinedicarboxylic acid 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-

ethyl methyl ester,(±)-(±)-ethylmethyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-

dimethyl-3,5-pyridinedicarboxylate [72509-76-386189-69-7]


质量标准: 

美国药典25版 

鉴别:符合规定 

A: 红外吸收 

干燥失重:≤0.5 % 

灼烧残渣:≤0.1% 

重金属:0.002% 

层析杂质: 

单个杂质≤1.0% 

总杂质≤1.5% 

含量: 98%~101%


Quality standard:

USP25

Identification:

A: Infrared Absorption

Loss on drying:≤0.5 %

Residue on ignition:≤0.1%

Heavy metal: 0.002%

Chromatographic Purity:

Individual purity≤1.0%

Total purity≤1.5% 

Assay: 98%~101%


非洛地平
非洛地平

4-pyridinecarboxylic acid, hydrazide. Isonicotinic acid hydrazide [54-85-3]



质量标准: 

美国药典25版 

鉴别:符合规定 

A: 红外吸收 

熔程:170℃~ 173℃

PH值:6.0~7.5 

干燥失重 ≤ 1.0% 

灼烧残渣:≤0.2% 

重金属:0.002% 

有机挥发杂质:符合要求 

含量: 98%~102%


Quality standard:

USP25

Identification:

A: Infrared Absorption

Melting range: 170℃~ 173℃

PH: 6.0~7.5

Loss on drying:≤ 1.0%

Residue on ignition:≤0.2%

Heavy metal: 0.002% 

Organic volatile impurities: meets the requirements

Assay: 98%~102%


异烟肼
异烟肼

质量标准: 国家药品监督管理局   Quality standard: S.D.A. of China

WS-10001-(HD-0226)-2002        WS-10001-(HD-0226)-2002


性状:黄色、黄绿色或浅棕黄色粉末         Characters: A yellow green-yellow or       light brown powder

其他羟乙基衍生物:峰面积之和≤20%      Other ramifications: Sum of Peak Area≤20%

PH值:5.0 ~ 7.0                          PH: 5.0 ~ 7.0

水分:≤ 4.0%                           Water: ≤ 4.0%

灼烧残渣:≤ 2.5%                       Residue on ignition: ≤ 2.5%

重金属:≤ 20ppm                        Heavy Metals: ≤ 20ppm

含量:≥80%                            Assay: ≥80%


曲克芦丁
曲克芦丁

质量标准:                   Quality standard:

中国卫生部94部颁标准       STANDARD OF THE HEALTH MINISTRY OF CHINA(94)


性状:白色或类白色粉末                DESCRIPTION: A WHITE CRYSTALLINE POWDER

熔点:151-154℃                       MELTING POINT: 151-154℃

溶液外观:无色透明                    SOLUTION CLEARLY: CLEAR

干燥失重:≤0.5%                      LOSS ON DRYING: ≤0.5%

炽灼残渣:≤0.1%                      RESIDUE ON IGNITION:≤0.1%

重金属:≤20 ppm                      HEAVY METALS: ≤20 ppm

酸度:5.0 - 7.0                       PH: 5.0 - 7.0

含量:≥ 99.0%                        ASSAY: ≥ 99.0%


吡拉西坦
吡拉西坦

Pregna-2,4-dien-20-yno[2,3-d]isoxazol-17-ol,(17α)-17α-pregna-2,4-dien-20-

yno[2,3-d]isoxazol-17-ol           [17230-88-5]


质量标准:                  Quality standard:

美国药典27版              USP 27


鉴别:符合规定                      Identification:

A: 红外吸收                         A: Infrared Absorption

B: 紫外吸收                         B: Ultraviolet Absorption

比旋度:+21°~ +27°                Specific rotation: between +21°and +27°

干燥失重: ≤ 2.0 %                  Loss on drying: ≤ 2.0 %

层析杂质:                          Chromatographic Purity:

单个杂质: ≤0.5%                      Individual purity: ≤0.5%

总杂质: ≤1.0%                        Total purity: ≤1.0%

含量: 97%~102%                      Assay: 97%~102%


达那唑
达那唑
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