Antibiotic Medium 12 (USP) - BioReagent

Cat. No.: A1528585

GRAU & PUREZA BioReagent

Storage

Room temperature

Shipped In

Normal

Visão geral

For microbiological assay of antibiotic potency

Especificações

Especificações e pureza

BioReagent

Condições de armazenamento de armazenamento

Room temperature

Enviado em

Normal

Grau

BioReagent

Product Line

Produtos biológicos

Application Protocols

No item-specific, validated application protocols are provided in the Product Data. For general guidance (literature/general):

• USP antibiotic potency assay (agar diffusion):
  • Prepare base and seed layers per USP, using Antibiotic Medium 12 where specified.
  • Standardize inoculum of the prescribed microorganism; apply reference standards and samples to wells/discs/tubes as defined by the method.
  • Incubate under defined conditions; measure inhibition zones and calculate potency using the compendial statistical approach.
• Turbidimetric assay (if applicable):
  • Prepare broth medium per USP; monitor growth by optical density relative to standards.

Always follow the exact USP monograph/SOP for your assay. Refer to the product’s CoA/Spec Sheet for any lot-specific preparation notes.

Biological Roles

As a standardized culture medium, Antibiotic Medium 12 (USP) serves as a nutrient and ionic environment to support the growth of specified microorganisms for antibiotic potency testing.

• Function: Provides carbon, nitrogen, vitamins, minerals, and buffering capacity (composition-dependent) to sustain robust, reproducible microbial growth and to yield consistent inhibition responses to antibiotics (literature/general).
• Assay relevance: The controlled formulation helps ensure that observed growth inhibition correlates with antibiotic concentration/potency rather than nutrient limitation or pH/ionic artifacts.
• Microbial scope: Intended for organisms specified in USP antibiotic assays that call for Medium 12. Growth characteristics and sensitivity profiles depend on the organism and test antibiotic as defined in the compendial method.
• Not a therapeutic: This product is not a drug and is provided strictly for laboratory research and quality control use.

Because this is a composite medium, individual biochemical pathways are not directly attributable to the product itself; instead, the medium supports general microbial metabolism (glycolysis, amino acid biosynthesis, respiration/fermentation) necessary for assay performance.

Buffer Applications

This product is not a dedicated buffer system. However, prepared media typically exhibit buffering capacity sufficient to maintain pH near neutrality during microbiological assays (literature/general).

• Use in practice:
  • Follow the USP monograph for any required pH adjustment of the reconstituted medium prior to sterilization and use.
  • If pH drift is observed after sterilization, allow medium to equilibrate to room temperature and recheck pH under prescribed conditions.
• Compatibility:
  • Avoid adding external buffers or salts unless explicitly permitted by the method, as changes can alter antibiotic activity or diffusion characteristics.
• Electrophoresis/cell culture: Not typically applicable; select dedicated electrophoresis buffers or mammalian cell culture media for those applications.

For specific pH targets, buffering agents, or titration details, refer to the USP method and the product’s CoA/Spec Sheet.

Green Alternatives

Sustainability for microbiological media focuses on responsible preparation and waste management rather than substituting chemical solvents.

• Resource efficiency:
  • Prepare only the quantities required for your assay to reduce waste of water and energy (autoclaving/sterilization burden).
  • Use energy-efficient sterilization cycles and validated lower-temperature/shorter-hold protocols where compendially acceptable.
• Waste minimization:
  • Deactivate biologically contaminated media via autoclaving or approved chemical disinfectants before disposal; segregate waste streams to reduce volume sent for biohazard treatment.
• Packaging considerations:
  • Choose larger pack sizes where feasible to reduce packaging per use, balanced against shelf-life and humidity exposure risk.
• Alternatives within method constraints:
  • If a compendial method allows alternative media numbers or formulations, select those that provide equivalent performance with fewer resource-intensive components (literature), but only after proper method verification/validation.

Comparison (general, literature):

• Dehydrated media prepared in-house vs. ready-to-use plates/broths: dehydrated formats reduce cold-chain and packaging but require on-site sterilization energy; ready-to-use formats save preparation time but may increase packaging and shipping footprint. Choose based on facility capabilities and sustainability priorities.

Pharmaceutical Uses

Intended for laboratory use in pharmaceutical quality control and research settings.

• Role: Culture medium for compendial microbiological assays of antibiotics (e.g., potency testing) specified by the United States Pharmacopeia. Supports standardized conditions for quantitative bioassays using reference standards and test samples.
• Status: Use as directed by the applicable USP chapter/monograph when Antibiotic Medium 12 is called for. This listing does not imply cGMP manufacture or pharmacopeial certification of the product itself unless stated on the CoA.
• Formulation activities: Not an excipient in drug products. Utilized in QC laboratories for method verification/validation, routine batch release testing, and stability study support where microbiological potency measurements are required.
• Documentation: Maintain full traceability (lot numbers, CoAs, preparation logs, equipment calibration) to satisfy audit requirements in regulated environments.

Note: No therapeutic or clinical claims are made. For regulatory use, ensure suitability-for-use studies are conducted per your quality system and compendial guidance.

Physical Properties

• Appearance: Not specified for this item; refer to CoA/Spec Sheet.
• Solubility: Designed to be reconstituted in purified/distilled water to prepare an aqueous culture medium (general property, literature). Exact solubility and turbidity characteristics depend on the formulation and water quality.
• pH (prepared medium): Typically adjusted near neutrality for microbiological testing (literature). Not specified for this item; refer to CoA/Spec Sheet and USP for target pH ranges measured at the defined temperature.
• Osmolality/ionic strength: Not specified for this item; refer to CoA/Spec Sheet.
• Density, BP, MP, refractive index, logP: Not applicable/reported for complex powdered media; Not specified for this item; refer to CoA/Spec Sheet.
• Hygroscopicity: Many dehydrated media are moderately hygroscopic; protect from moisture ingress to maintain performance (general guidance, literature).

Prepared medium characteristics (literature/general):

• Clear to slightly opalescent after sterilization, depending on composition and water quality.
• May form soft gels or remain liquid depending on whether agar is included; agar content is formulation-dependent and not specified here.

Always verify lot-specific physical parameters on the CoA, and follow USP directions for preparation, pH adjustment, and sterilization.

Quality and Grades

• Grade/Purity (item-specific): BioReagent.
  • BioReagent grade indicates suitability for biological research workflows, with controlled bioburden and performance attributes appropriate for life science applications. It does not imply pharmaceutical-grade manufacture unless explicitly stated.
• Standard alignment: Formulated for use as Antibiotic Medium 12 (USP). Users conducting compendial tests should verify compliance with the relevant USP chapter/monograph for their application.
• What this means in practice:
  • Batch-to-batch consistency is critical for potency assay reproducibility; consult the Certificate of Analysis (CoA) for performance checks (e.g., pH of prepared medium, growth promotion/inhibition suitability tests, if provided).
  • UV-absorbing impurities, elemental profiles, and other analytical specifications: Not specified for this item; refer to CoA/Spec Sheet.
• Stabilizers/defomers/indicators: Not specified for this item; refer to CoA/Spec Sheet.
• Documentation: For regulated QC, retain CoA and preparation records. If used in validated USP methods, perform verification with assay organisms and reference standards as required by your QA system.

Reaction and Applications

Chemical reaction use is not typical for this product. Instead, its primary application is microbiological assay support:

• Use case: Preparation of plates or broths for USP antibiotic potency testing via agar diffusion or turbidimetric methods (literature). The medium composition is tuned to yield reproducible microbial growth and well-defined inhibition zones with specified test organisms and reference standards.
• Methodological context:
  • Suitable for standardized inoculum preparation and assay layers per USP procedures when Medium 12 is specified.
  • Ensures consistent buffering/nutrient balance to minimize matrix effects on antibiotic activity readouts.
• Practical considerations:
  • Prepare with high-purity water; adjust pH per USP before sterilization if required by the monograph (literature). Avoid overheating or prolonged autoclaving which may degrade nutrients.
  • Validate performance with growth promotion/inhibition controls using compendial strains and reference antibiotics, consistent with your QA program.
  • Avoid introducing chelators, detergents, or antibiotic residues from labware that could bias activity measurements.

Note: For synthetic chemistry needs, this medium provides no specific catalytic or reagent functionality; select appropriate chemical reagents instead.

Reaction Conditions

Chemical reaction parameters (solvent, temperature, catalysts) are not applicable. For its intended use in microbiological assays:

• Preparation conditions (general, literature):
  • Reconstitute the powder in high-purity water with stirring. Adjust pH as required by the USP method, if specified.
  • Sterilize by validated procedures (e.g., autoclaving) appropriate for the formulation and container type. Avoid prolonged overheating that can degrade nutrients.
  • Pour plates or dispense broths under aseptic conditions. Allow plates to dry/surface equilibrate before use as directed by the assay.
• Assay conditions: Incubation temperature, inoculum density, and timing are strictly method-dependent; consult the relevant USP monograph. Do not substitute organisms or parameters without method verification.

For exact preparation and incubation parameters, refer to the USP and the product CoA/Spec Sheet.

Safety and Handling

• GHS classification / pictograms / H-statements: Not specified for this item; refer to SDS.
• Primary hazards (general for dehydrated media): Low acute chemical hazard under normal handling; nuisance dust may cause mechanical eye/respiratory irritation. Avoid inhalation and contact with eyes/skin. Once reconstituted and inoculated, treat as biohazard per institutional biosafety procedures.
• PPE: Laboratory coat, safety glasses, and appropriate gloves; use dust mask/respirator if airborne dust is generated (per risk assessment). Work in a clean area to avoid microbial contamination during media preparation.
• Incompatibilities: Avoid moisture uptake during storage; keep container tightly closed. Do not mix with oxidizers, strong acids/bases unless directed by validated preparation procedures.
• Handling: Minimize dust generation. Use dedicated utensils to prevent cross-contamination. Prepare with high-purity water. If sterilization is required, follow autoclave procedures compliant with USP and institutional SOPs.
• First aid (overview): If inhaled, move to fresh air; for eye contact, rinse cautiously with water; for skin contact, wash with soap and water. Seek medical advice if irritation persists. Refer to SDS for full guidance.
• Waste: Dispose of unused dry medium per local regulations. Any used/contaminated medium should be autoclaved or chemically disinfected before disposal, following biosafety rules.

Always defer to the product SDS and your institution’s EHS policies for authoritative safety information.

Solvent Selection

This product is a microbiological medium intended to be reconstituted in high-purity water.

• Primary solvent: Purified, distilled, or deionized water of appropriate quality for microbiological media preparation (e.g., meeting in-house RO/DI or pharmacopeial water specs as applicable). Avoid organic solvents.
• Polarity/miscibility: On reconstitution, components are water-soluble or water-dispersible (literature/general). Insoluble traces may appear as benign particulates; follow USP clarification guidance if applicable.
• When to choose this medium: Select when executing USP antibiotic potency assays specifically calling for Antibiotic Medium 12. For other assays, match the medium number/formulation to the compendial method.
• Practical tips:
  • Add powder to water with efficient stirring to minimize clumping. Adjust preparation temperature as needed to aid dissolution (avoid overheating beyond method instructions).
  • Use freshly prepared medium; if storage of prepared medium is permitted, follow validated hold times/temperatures and protect from contamination.
• Comparison to alternatives (general): Different USP Antibiotic Media (e.g., Nos. 1–20, literature) vary in nutrient balance and ionic content to optimize growth/inhibition for specific organisms/antibiotics. Substitutions should be justified by method verification/validation.

Storage and Reconstitution

• Storage (item-specific): Room temperature. Keep container tightly closed, dry, and protected from humidity. Shipped under normal conditions.
• Reconstitution:
  • Use freshly produced high-purity water. Add powder gradually with stirring to ensure complete dissolution/dispersion.
  • Adjust pH only if required by the applicable USP monograph and verify at the prescribed temperature.
  • Sterilize by validated procedures compatible with the formulation and packaging (e.g., autoclaving), unless using sterile-filterable components as permitted by the method.
• Prepared medium:
  • If storage of prepared plates/broth is permitted, hold at temperatures and for durations validated by your laboratory SOPs. Protect plates from desiccation and contamination.
  • Label with lot number, preparation date, and expiration/retire date per QA requirements.
• Freeze–thaw: Not applicable; do not freeze dehydrated medium. Avoid repeated heating/cooling cycles of prepared media.

For exact preparation quantities (e.g., grams per liter), target pH, and sterilization parameters, Not specified for this item; refer to CoA/Spec Sheet and the relevant USP monograph.

Structure and Identity

Antibiotic Medium 12 (USP) is a complex, multi-component microbiological culture medium standardized by the United States Pharmacopeia for antibiotic potency testing.

• Item nature: Complex mixture (dehydrated medium or blend); not a single defined chemical substance.
• Intended standard: Conforms to USP methodology for antibiotic assays (general informational note; consult the applicable USP chapter/monograph for exact details).
• Molecular formula / Molecular weight: Not applicable to mixtures. Not specified for this item; refer to CoA/Spec Sheet.
• CAS, SMILES, InChIKey: Not applicable to mixtures. Not specified for this item; refer to CoA/Spec Sheet.
• Structural features (descriptive): As a complex medium, it typically comprises nutrient sources (e.g., peptones/tryptones, extracts), salts, and buffers designed to support growth of specified microorganisms and yield reproducible inhibition zones in antibiotic bioassays. Exact qualitative/quantitative composition is governed by the USP monograph (literature) and may vary by manufacturer within allowable tolerances.
• Physical form: Typically supplied as a homogeneous powder blend for reconstitution (general description; see product label/CoA for this lot).

Note: Because it is a standardized mixture, single-compound identifiers (SMILES, InChI) are not meaningful. Always refer to the product CoA and the USP chapter for authoritative identity and composition details.

Synthetic Utility

Not applicable for classical chemical synthesis. Antibiotic Medium 12 (USP) is a microbiological culture medium and does not function as a reagent, catalyst, or solvent in organic or inorganic synthesis.

• If your workflow involves chemical synthesis, select dedicated reagents/solvents/catalysts. This medium should be reserved for microbiological assay preparation as specified by USP methods.

Target Specificity

Not applicable. This product is a culture medium and does not possess target-binding specificity (e.g., no antigen/epitope recognition, clone, or isotype). No item-specific immunochemical data are provided.

Perguntas frequentes

How should this product be stored?

Store at room temperature.