Diluting Fluid A (Peptone Saline Diluent) | AS-1413 | AuSaMicS Melbourne
Diluting Fluid A
Dehydrated powder medium for preparation of Fluid A used in sterility testing and pharmaceutical microbiology workflows. Supplied in dry form, not as a sterile ready-to-use liquid.
Product Description
Diluting Fluid A is supplied as a dehydrated powder medium intended for preparation of compendial-style Fluid A for sterility testing. After reconstitution, the prepared medium serves as a low-nutrient diluting and rinsing fluid designed to preserve microbial viability during handling while minimizing growth.
Typical applications
- Rinsing membranes during sterility testing by membrane filtration.
- Dilution or dissolution of soluble or aqueous test articles before sterility testing.
- Short-term suspension of microorganisms where viability should be preserved.
- General pharmaceutical microbiology workflows requiring a simple non-inhibitory diluent.
Technical Specifications:
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Product: Diluting Fluid A (Peptone Saline Diluent)
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Catalogue No: AS-1413
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Manufacturer: AuSaMicS Life Science (Melbourne, VIC)
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Standards: USP <61>, USP <62>, EP 2.6.12, EP 2.6.13 Compliance
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Composition: 0.1% Peptone Water (pH 7.1 ± 0.2)
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Key Use: Rinsing fluid for membrane filtration and dilution of samples in microbial limit testing.
Question: What is Diluting Fluid A used for? Answer: Diluting Fluid A is a sterile 0.1% peptone solution used as a rinsing and diluting agent in microbiological examinations, specifically for membrane filtration as per USP/EP/JP harmonized standards. AuSaMicS AS-1413 provides a reliable, locally stocked alternative in Australia.
| Parameter | Specification |
|---|---|
| Product format | Dehydrated powder medium. |
| Composition per litre of prepared medium | Peptic digest of animal tissue 1.0 g; purified water to 1 litre. |
| Reconstitution | Suspend 1.0 g in 1000 mL purified water and dissolve completely. |
| Typical sterilization practice | Sterilize the prepared medium using the laboratory's validated preparation procedure. A commonly used cycle is 121°C for 15 minutes. |
| Final pH after preparation | 7.1 ± 0.2 at 25°C. |
| Appearance | Powder: light beige to amber, free-flowing. Prepared medium: clear, colourless to pale yellow solution. |
| Storage | Store dry at 10-30°C, tightly closed, protected from moisture and light. |
AS-1413 Cross-Reference Compatibility:
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Oxoid: Alternative to BO0833 / TV5001 (Peptone Saline)
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BD Difco: Alternative to 214971
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Merck: Alternative to 1.46341
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Hardy Diagnostics: Alternative to U115
Technical Data Sheet
| Parameter | Specification |
|---|---|
| Format | Dehydrated powder medium for preparation of Fluid A. |
| Use | Diluting and rinsing fluid for sterility testing after reconstitution. |
| Preparation | Suspend 1.0 g in 1000 mL purified water; dissolve completely; sterilize by the validated laboratory procedure. |
| pH after preparation | 7.1 ± 0.2 at 25°C. |
| Appearance - dehydrated medium | Light beige to amber, free-flowing homogeneous powder. |
| Appearance - prepared medium | Clear, colourless to pale yellow solution. |
| Storage | 10-30°C, dry place, tightly closed, protected from moisture and direct light. |
Use in accordance with the laboratory's validated sterility testing SOP and method suitability program.
Safety Data Sheet Summary
| Item | Statement |
|---|---|
| Classification | Not classified as a hazardous chemical under GHS 7 as adopted in Australia. |
| Signal word | None. |
| Form supplied | Dehydrated powder medium. |
| Handling | Avoid inhalation of dust and avoid contact with eyes. Follow normal laboratory hygiene. |
| Storage | Store dry at 10-30°C, protected from moisture and light. |
| Transport | Not classified as dangerous goods for transport based on available comparable information. |
Certificate of Analysis Template
| Test | Specification |
|---|---|
| Appearance - dehydrated medium | Light beige to amber, free-flowing homogeneous powder. |
| Appearance - prepared medium | Clear, colourless to pale yellow solution after reconstitution. |
| pH at 25°C | 7.1 ± 0.2 after preparation. |
| Solubility | Completely soluble at stated preparation concentration. |
| Sterility of prepared medium | No evidence of contamination in release sterility check where applicable. |
Batch-specific values, lot number, dates and signatures must be completed from actual QC release data before issue.