Antibiotic Medium 11 (USP) - BioReagent

Cat. No.: A1528568

GRADE & PURITY BioReagent

Storage

Room temperature

Shipped In

Normal

Descripción general

For microbiological assay of antibiotic potency. Preparation method: Weigh 30.5 g of this product, dissolve in 1 L of distilled or deionized water, heat with stirring and boil until completely dissolved, dispense, autoclave at 121°C for 15 minutes. After sterilization, shake well to prevent agar from settling and solidifying at the bottom, then set aside for use.

Specifications

Especificaciones y pureza

BioReagent

Condiciones de almacenamiento de almacenamiento

Room temperature

Enviado en

Normal

Grado

BioReagent

Product Line

Productos biológicos

Application Protocols

Below are general, literature-based workflow outlines for compendial microbiological assays using USP antibiotic media. These are provided for context; follow current USP and your validated SOPs. Item-specific parameters are Not specified for this item; refer to CoA/Spec Sheet.

A. Agar diffusion assay (general):

• Reconstitute the medium in purified water at the USP-prescribed concentration; sterilize by autoclaving.
• Cool to ~45–50 °C and pour plates to a uniform depth; allow to solidify and dry to a consistent surface.
• Prepare standard and sample antibiotic solutions; inoculate plates with the designated test organism lawn.
• Apply standards/samples to wells or discs; incubate at the specified temperature/time.
• Measure inhibition zones; construct a standard curve from reference standards and determine potency of samples.

B. Turbidimetric (broth) assay (general):

• Reconstitute and sterilize broth per USP; equilibrate to incubation temperature.
• Inoculate with standardized organism suspension; add serial dilutions of standards and test solutions.
• Incubate to the defined endpoint; measure turbidity (OD) and compute potency from the standard curve.

Controls and QC:

• Perform growth promotion testing for each new lot.
• Verify pH and sterility of prepared medium.
• Include negative controls (no antibiotic) and appropriate system suitability criteria.

Biological Roles

As a formulated culture medium, Antibiotic Medium 11 (USP) provides the nutrients, ionic balance, and buffering capacity required to support growth of specific indicator microorganisms used in compendial antibiotic potency assays.

General/literature context:

• Supplies carbon and nitrogen sources (e.g., from peptones/yeast components) and essential growth factors to sustain the designated test strain(s).
• Maintains a controlled pH environment conducive to reproducible microbial growth and antibiotic activity expression during the assay interval.
• In agar formats, the gel matrix provides a diffusion medium enabling clear and measurable inhibition zones for agar diffusion assays.
• In turbidimetric (broth) assays, the medium’s composition supports predictable growth kinetics, allowing correlation of optical density changes to antibiotic concentration.

Note:

• The biological role is strictly methodological: it enables standardized microbial response under USP conditions. It is not a therapeutic or nutritional product for animals or humans.
• Specific test organisms and growth responses are defined in the USP monograph for Antibiotic Medium 11. Consult current compendia and your SOPs for organism selection and inoculum preparation.

Buffer Applications

Not primarily a buffering reagent. While the prepared medium exhibits a controlled pH per USP to support microbial assays, it is not intended to be used as a standalone buffer system.

Practical notes (literature):

• If pH adjustment is required during preparation, use sterile acid/base (e.g., HCl/NaOH) as permitted by USP and confirm the final pH after sterilization.
• For dedicated buffering needs (e.g., enzyme assays unrelated to microbiological potency testing), select a defined buffer (phosphate, MOPS, HEPES) with known pKa and ionic strength rather than a complex medium.

Green Alternatives

Green chemistry considerations for culture media focus on waste reduction, energy use, and material efficiency rather than solvent substitution.

Strategies (general):

• Right-size preparation: Reconstitute only the volume needed to minimize discarded sterilized media.
• Energy efficiency: Consolidate autoclave cycles and use validated liquid-cycle parameters to reduce energy consumption while maintaining sterility assurance.
• Material choices: Prefer reusable glassware (flasks, bottles) where feasible to reduce single-use plastics. If using plates, evaluate recyclable or lower-mass formats compatible with your workflow.
• Process water: Maintain water systems to minimize flushing and rework due to quality deviations.

Alternatives/comparisons (context, literature):

• Some laboratories employ ready-to-use sterile media to reduce in-house autoclaving; this can save energy on-site but may increase transport packaging. Conduct a life-cycle assessment for your facility.
• When the USP method allows different media numbers for specific antibiotics, select the medium that meets method requirements with the fewest preparation steps and lowest failure risk to minimize repeats and waste.

Disposal:

• Autoclave inoculated media prior to disposal; separate agar-containing solids from liquids according to local regulations to enable appropriate waste handling.

Pharmaceutical Uses

Context of use: research and quality control only. No medical/clinical application is claimed.

Quality control and manufacturing (literature):

• Employed in compendial microbiological assays for determining the potency of antibiotic drug substances and products per USP procedures associated with Antibiotic Medium 11.
• Supports method verification/validation in GMP environments when testing finished products, in-process materials, or reference standards according to pharmacopeial requirements.
• May be referenced in regulatory submissions as part of the microbiological assay methodology, with lot traceability, growth promotion testing, and documentation of USP conformity.

Excipient/formulation status:

• This is a laboratory reagent, not an excipient for drug product formulation.

Compliance note:

• Maintain records of lot numbers, CoAs, growth promotion test results, and preparation logs to meet data integrity expectations during audits.

Physical Properties

Item-specific physical constants are not provided for this product because it is a complex mixture. Typical properties for dehydrated microbiological media are given as general literature guidance only.

Item-specific (from Product Data):

• Appearance: Not specified for this item; refer to CoA/Spec Sheet.
• Storage: Room temperature (per Product Data).
• Shipping: Shipped under normal conditions (per Product Data).

General/literature characteristics for dehydrated USP media (non-spec, for context):

• Physical form: Free-flowing, homogeneous powder or granules.
• Color: Beige to light tan, may vary by lot and composition.
• Solubility: Intended to be water-soluble/dispersible at the USP-prescribed preparation (literature). Some particulate may remain before sterilization.
• pH (prepared medium): Controlled within a USP-specified range at 25 °C after sterilization (literature). Exact pH range is monograph-specific; Not specified for this item; refer to CoA/Spec Sheet.
• Sterilization: Typically by autoclaving after dissolution per USP protocol (literature).

No boiling point, melting point, refractive index, logP, or precise density are meaningful for this multi-component solid mixture. For batch attributes such as moisture content, pH of prepared medium, gel strength (if agar-containing), and clarity, consult the lot CoA.

Quality and Grades

• Grade: BioReagent (per Product Data) — suitable for biological research applications and media preparation.
• USP designation: Indicates that the formulation is intended to meet the United States Pharmacopeia requirements for Antibiotic Medium 11 when prepared and sterilized according to the monograph (literature). This supports method suitability and consistency in antimicrobial potency assays.

What this means in practice:

• Composition and performance characteristics (e.g., growth promotion, pH after sterilization) are specified by the USP monograph. Vendors typically verify lots against these criteria; confirm with the lot CoA and any performance certificates.
• Low bioburden and absence of inhibitory contaminants is critical for assay reproducibility. BioReagent grade reflects controls appropriate for culture media manufacture.

Item-specific notes:

• Stabilizers, UV cutoff, trace metals, and other analytical-grade solvent metrics are not applicable for culture media and are not specified.
• For regulatory or QC environments, retain documentation of USP compliance per lot and perform in-house growth promotion tests with the prescribed test organisms.

Recommendation:

• For critical assays, qualify each lot using your laboratory’s method suitability protocol (organism challenge, diffusion/zone response, pH verification) before routine use.

Reaction and Applications

This product is not used as a chemical reagent for synthetic reactions. Its applications are microbiological and analytical.

Core applications (literature, USP context):

• Antibiotic potency assays: Preparation of plates or broths for microbiological assay of antibiotics using agar diffusion or turbidimetric methods as specified by USP for Antibiotic Medium 11.
• Method suitability/validation: Verification of growth promotion, inhibition profiles, and response factors for designated test organisms relevant to the specific antibiotic under test.
• Routine QC: Use in pharmaceutical quality control laboratories for batch-release testing of antibiotic products following compendial procedures.

Practical tips:

• Follow the USP monograph for Antibiotic Medium 11 precisely, including medium concentration, pH targets, sterilization cycle, and test organism selection.
• Standardize inoculum density (e.g., McFarland standards or spectrophotometric OD) to ensure consistent diffusion zones or turbidity response.
• Control plate depth and solidification conditions when agar is used, as these affect diffusion and zone diameters.
• Include compendial reference standards and assay controls to establish the standard curve for potency determination.

Note: Specific organisms and preparation parameters are dictated by the USP monograph for Antibiotic Medium 11. Refer to current USP and your internal SOPs.

Reaction Conditions

Not applicable to chemical reactions. For microbiological assay preparation, follow compendial conditions.

General/literature preparation conditions for USP media (context, not item-specific):

• Solvent: Purified water.
• Dissolution: Add the prescribed grams per liter per USP monograph; heat with stirring to dissolve/disperse fully.
• Sterilization: Autoclave using validated cycle (e.g., gravity or liquid cycle) per institutional SOP; avoid overheating to prevent component degradation.
• Cooling/dispensing: For agar plates, cool to ~45–50 °C before pouring; for broths, dispense aseptically while hot as appropriate.
• pH: Verify after sterilization meets USP target.

Exact concentrations, pH targets, and organisms are monograph-specific and are Not specified for this item; refer to CoA/Spec Sheet and current USP.

Safety and Handling

Handle as a laboratory reagent for microbiological media preparation. While most dehydrated media are of low acute toxicity, dusts may cause mechanical irritation.

• GHS classification: Not specified for this item; refer to SDS.
• Signal word / H-statements / pictograms: Not specified for this item; refer to SDS.
• Primary hazards (general):
  • Dust inhalation may irritate respiratory tract; avoid aerosol generation.
  • Eye/skin contact may cause irritation; wash thoroughly after handling.
  • Biological risk arises only after inoculation; treat all inoculated media as biohazardous.
• Incompatibilities (general): Strong oxidizers and moisture. Keep container tightly closed to prevent caking/contamination.
• PPE: Lab coat, safety glasses, and appropriate gloves. Use a dust mask/respirator where dust cannot be controlled (per institutional risk assessment).
• First aid (overview):
  • Inhalation: Move to fresh air; seek medical attention if symptoms persist.
  • Skin: Wash with soap and water.
  • Eyes: Rinse cautiously with water for several minutes; remove contact lenses if present and easy; continue rinsing.
  • Ingestion: Rinse mouth; seek medical advice if unwell.
• Handling tips:
  • Weigh in a clean, dry environment to avoid moisture uptake.
  • Use sterile technique after sterilization to avoid contamination.
  • Decontaminate used plates/broths by autoclaving prior to disposal.

Always consult the SDS for authoritative, lot-specific safety information.

Solvent Selection

Not typically applicable to this product as a dehydrated culture medium. The intended solvent is purified water to prepare broths/agars per USP.

Practical guidance (literature, general):

• Use purified water meeting USP/EP specifications or laboratory-grade DI water. Water quality affects pH and clarity.
• Dissolution: Add medium to water with gentle heating and stirring until fully dispersed; avoid overheating or localized scorching.
• pH adjustment (if prescribed): Adjust before sterilization using sterile acid/base solutions per USP method.

Comparison to alternatives (context):

• Unlike buffer concentrates or organic solvents, culture media are reconstituted solely in water; organic solvents are not appropriate for routine preparation or sterilization of this medium.

Storage and Reconstitution

• Storage conditions (per Product Data): Room temperature in tightly closed container. Protect from moisture and contamination.
• Shipping: Normal conditions (per Product Data).
• Research Use: For research use only (per Product Data).

Reconstitution (general literature guidance; not item-specific):

• Use purified/DI water. Gradually add the dehydrated medium with stirring to prevent clumping; heat gently to aid dissolution.
• Adjust pH if required by the current USP monograph. Do not over-adjust; verify pH after sterilization.
• Sterilize by autoclaving per validated cycle. For agar media, cool to 45–50 °C before pouring plates.
• Label prepared media with lot number, preparation date, and expiration per your SOPs.

Shelf-life notes:

• Unopened, store dry at room temperature; avoid high humidity and temperature excursions.
• Once opened, reseal promptly. Consider desiccant and secondary containment to limit moisture uptake.
• Prepared media have limited shelf-life depending on format and storage; establish in-house expiry dating aligned with USP and institutional guidance.

For any item-specific parameters (g/L, pH targets, sterilization cycle, growth promotion organisms), Not specified for this item; refer to CoA/Spec Sheet and the current USP monograph for Antibiotic Medium 11.

Structure and Identity

Antibiotic Medium 11 (USP) is a defined microbiological growth medium specified by the United States Pharmacopeia for antibiotic potency testing. It is a formulated mixture rather than a single, discrete molecule.

• SKU: A1528568
• Product name: Antibiotic Medium 11 (USP)
• Type: Dehydrated culture medium (complex mixture); composition defined by USP monograph (literature)
• Molecular formula: Not applicable to mixtures; Not specified for this item; refer to CoA/Spec Sheet.
• Molecular weight: Not applicable to mixtures; Not specified for this item; refer to CoA/Spec Sheet.
• SMILES / InChI / InChIKey: Not applicable to mixtures; Not specified for this item; refer to CoA/Spec Sheet.

Structural features (general, literature):

• Contains carbon sources, nitrogen/peptone/yeast extracts, mineral salts, and buffering components typical of USP antibiotic assay media.
• No stereochemistry or single-ring systems apply; the product is a heterogeneous blend of organic and inorganic constituents designed to support growth of designated test organisms and to provide a consistent matrix for antimicrobial diffusion/potency assays.

Identity notes:

• The term “USP” denotes compliance with the medium specification in the United States Pharmacopeia for microbiological assay procedures. Exact component list and ranges are governed by the USP monograph. Always confirm the lot-specific CoA for conformity.

Synthetic Utility

Not applicable. Antibiotic Medium 11 (USP) is not a synthetic building block, catalyst, or reagent. It serves as a microbiological culture medium for analytical assays.

For chemical synthesis applications, refer to dedicated reagents, catalysts, and solvents designed for the target transformations.

Target Specificity

Not an antibody or affinity reagent. No antigen/epitope/clone specificity applies.

Assay specificity (context): In compendial use, specificity is defined by the combination of this medium with designated test organisms and antibiotic reference standards per USP. Consult the USP monograph for Antibiotic Medium 11 for organism selection and assay parameters.