Specification for Sterilized water for Injection
This article contains specification for sterilized water for Injection 05 ml (SWFI)
Specification for sterilized water for Injection 05 ml (SWFI)
Product Information:
| Supplier / Manufacturer : | As per approved vendor list |
| Sampling Procedure: | Sampling to be performed as per current version of SOP |
| Sample Quantity : | 70 vials. |
| Testing procedure: | Testing to be performed as per respective current STP. |
| Item code | As per SOP |
| Storage Condition: | Controlled Room temperature. |
| Sampling and Handling Precautions
(If Any): |
Use personal protective equipment’s while handling the material. |
Specification for water for injection:
| Sr. No. | Test | Specification | Reference |
| 1. | Description | Clear and colorless liquid. | IH |
| 2.
|
Chemical Test for sterilized water for Injection | ||
| 2.1 | Acidity or alkalinity | If the solution is yellow, it becomes red on the addition of 0.1 ml of 0.01 M NaOH ; if red, it becomes yellow on the addition of 0.15 ml of 0.01 M hydrochloric acid. | IH |
| 2.2 | Conductivity | Maximum 25 µS·cm-1 for containers with a nominal volume of 10 ml or less. | IH |
| 2.3 | Oxidizable substances | The solution remains faintly pink. | IH |
| 2.4 | Chlorides | Maximum 0.5 ppm for containers with a nominal volume of 100 ml or less. | IH |
| 2.5 | Nitrates | Maximum 0.2 ppm. | IH |
| 2.6 | Sulfates | The solution shows no change in appearance for At least 1 hr. | IH |
| 2.7 | Ammonium | maximum 0.6 ppm | IH |
| 2.8 | Calcium and magnesium | A pure blue colour is produced. | IH |
| 2.9 | Residue on evaporation | Maximum 4 mg (0.004 %) | IH |
| 3.0. | Particulate contamination | A. 6000 per container equal to or greater than 10 µm
B. 600 per container equal to or greater than 25 µm. |
IH |
| 4.0 | Microbial Limit Test for sterilized water for Injection | ||
| 4.1 | Sterility | Should be Sterile. | IH |
| 4.2. | Bacterial endotoxins (BET) | Less than 0.25 IU/ml. | IH |
Remark: * Test to be carried out for Retesting of sterilized water for Injection
III Revision History :
| Version No. | Reason for Revision | Change control No | Effective Date |
IV: Abbreviations:
IH : Inhouse
SOP : Standard operating procedure
STP : Standard test procedure
PPM : Parts per million.
SWFI : Sterilized water for Injection
