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Specifications

Potassium

Phosphates

Bromide

Loss on drying

Acidity or alkalinity

Bacterial endotoxins

Appearance of solution

Assay

Identification

Test items

9876

5

4321

ft3.2 Drug substance specification: Sodium chloride USP34-36

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Heavy metals

Iron

Bacterial endotoxins

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pH

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7

6

5432

1

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Specifications

Iron

Bacterial endotoxins

Sterility test

PH

Assay

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6

5432

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Heavy metals

Nitrites

Sulfate

Ferrocyanides

Barium

Iron

Arsenic

Magnesium and alkaline-

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Aluminium

Iodides

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17

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titration does not exceed 2.5 ml or Not more than 100 ppm,

calculated as Ca

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Specifications

Nitrites

Sulfate

Ferrocyanides

Barium

Iron

Arsenic

Magnesium and

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metals

Aluminium

Iodides

Potassium

Phosphates

Bromide

Loss on drying

Acidity or alkalinity

Bacterial endotoxins

Appearance of

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Assay

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18

17

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in the reference.

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titration does not exceed 2.5 ml or Not more than 100 ppm,

calculated as Ca

- Not more than 0.2 ppm

- No blue color is observed.

- Not more than 500 ppm

- Not more than 25 ppm

- Not more than 100 ppm

- Not more than 0.5%

- Not more than 0.5 ml of 0.01 N hydrochloric acid or 0.01 N sodium

hydroxide is required to change the color of this solution.

- Not more than 0.5 USP Endotoxin Unit/ml or Not more than

5EU/g

- The solution is clear and colorless

- 99.0-100.5 % on the drided basis

- Meet the requirement

Specifications

Nitrites

Sulfate

Ferrocyanides

Barium

Iron

Arsenic

Magnesium and

alkaline-earth metals

Aluminium

Iodides

Potassium

Phosphates

Bromide

Loss on drying

Acidity or alkalinity

Bacterial endotoxins

Appearance of solution

Assay

Identification

Test items

18

17

16

15

14

13

1211

1098

7

6

5

4321

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3.5 Drug substance specification: Sodium chloride USP 39

n.vi.

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- Maximum 200 ppm

- Maximum 25 ppm

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- Maximum 100 ppm

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sodium hydroxide is required to change the color of the

indicator.

- 99.0-100.5 % on the drided substance

- Meet the requirement

Specifications

Iron

Barium

Arsenic

Aluminium

Sulfates

Phosphates

Nitrites

Iodides

Ferrocyanides

Bromide

Acidity or alkalinity

Assay

Identification

Test items

13

12

11

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3.7 Drug substance specification: Sodium chloride BP 2011-2016

- Not more than 0.25 lU/ml

- Meet the requirement

- 95.0-105.0 % of the labeled amount of sodium chloride

- Meet the requirement

Specifications

Bacterial endotoxins

Sterility test

Assay

Identification

Test items

4321

3.6 Finished product specification: Sodium chloride Irrigation Solution BP 2011-2016

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Maximum 0.5%Loss on drying17

Maximum 5 ppmHeavy metals16

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Maximum 100 ppm, calculated as CaMagnesium and alkaline-

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Verapamil 240 mg Prolonged-Release

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Sodium chloride 0.9% Irrigating Solution

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Ciprofloxacin 400 m/200 ml Injection

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