Antibiotic Medium 36 (USP) - BioReagent

Cat. No.: A1528571

GRADE & PURITY BioReagent

Storage

Room temperature

Shipped In

Normal

Vue d’ensemble

For microbiological assay of antibiotic potency

Specifications

Spécifications et pureté

BioReagent

Conditions de stockage de stockage

Room temperature

Expédié en

Normal

Grade

BioReagent

Product Line

biological_products

Application Protocols

No item-specific, vendor-validated application protocols are provided for this listing. Refer to the current USP monograph for Antibiotic Medium 36 for authoritative procedures. Below are general steps for context only (literature/general), not a substitute for compendial methods.

• General preparation outline

  • Weigh the dehydrated medium according to the USP-specified concentration. Suspend in purified/DI water with stirring until fully dissolved.
  • Sterilize as directed (commonly by autoclaving). If agar plates are required, dispense molten medium into sterile plates to the specified depth; allow to solidify under aseptic conditions.
  • If supplements are required by the monograph, aseptically add after cooling to an appropriate temperature.

• Assay setup (general)

  • Standardize inoculum density of the designated organism(s) per USP. For agar diffusion, seed layers and plate thickness must meet monograph tolerances; for turbidimetric assays, calibrate optical density readings and incubation timing.
  • Prepare pharmacopeial reference standards and sample solutions in the specified diluents; construct standard curves each assay day.

• Controls and suitability (general)

  • Perform growth-promotion or assay-suitability tests as required. Reject plates/batches that fall outside USP acceptance criteria.

For regulated work, always follow the USP text verbatim and record lot numbers, preparation parameters, and results for QA traceability.

Biological Roles

As a microbiological culture medium, Antibiotic Medium 36 (USP) provides nutrients and environmental conditions to support standardized microbial growth responses used in antimicrobial potency assays.

• Functional role (general)

  • Supplies amino acids, peptides, vitamins, minerals, and energy sources in proportions defined by the USP monograph to elicit reproducible growth of designated test organisms.
  • Maintains a controlled pH and osmotic environment suitable for zone-of-inhibition or turbidimetric quantitation of antibiotic activity.

• Assay context (general/USP)

  • In microbiological assays, biological response (growth/no growth; zone diameter or turbidity) serves as the readout correlating to antibiotic concentration when compared against compendial reference standards.
  • Medium composition, pH, and incubation parameters modulate organism sensitivity; hence the specific USP medium number (e.g., 36) is part of the standardized system to balance sensitivity and robustness for the targeted antibiotics.

• Relevance to biochemistry (general)

  • Complex nitrogen sources (peptones/tryptones) provide a broad spectrum of peptides and amino acids, supporting rapid biomass formation.
  • Trace components from yeast/meat extracts contribute growth factors (e.g., B-vitamins) that enhance metabolic pathways required for assay organisms.

• Limitations (general)

  • Medium is not intended for mammalian cell culture or molecular biology enzyme reactions. Its undefined composition is advantageous for robust microbial growth but unsuitable where chemically defined conditions are required.

No clinical or therapeutic claims are implied; this product is for research and laboratory use only.

Buffer Applications

This product is a complex culture medium rather than a discrete buffering agent. While prepared media exhibit a defined pH suitable for the assay organisms, it is not used as a general laboratory buffer system.

• Applicability

  • Not typically used for standalone buffering applications or electrophoresis. Any pH control is intrinsic to the USP formulation and must not be altered for compendial assays.

• Practical note (general)

  • If pH adjustment is specified during preparation by the USP monograph, use dilute acid/base and measure at the temperature indicated in the method. Over-adjustment can impair microbial response and invalidate potency results.

For routine buffer needs (e.g., phosphate, Tris), choose dedicated buffer systems; for antibiotic potency assays, use the medium exactly as defined by USP.

Green Alternatives

Green chemistry comparisons (solvent substitutions, low-toxicity reagents) are not directly applicable to a dehydrated culture medium. Nonetheless, sustainable practices can be applied to its preparation and use.

• Resource efficiency (general)

  • Prepare only the volume needed for near-term assays to minimize waste from expired sterile media.
  • Use energy-efficient sterilization cycles validated for your load size (e.g., fractional loads or liquid cycles that meet sterility assurance without excessive dwell time).

• Waste minimization (general)

  • Segregate non-biohazard unused medium from biohazard waste to reduce high-temperature incineration volume.
  • For inoculated/used media, apply validated decontamination (autoclave) prior to disposal following institutional and local regulations.

• Packaging and storage (general)

  • Reseal promptly with desiccant to extend shelf life and reduce spoilage-related waste.
  • Consider bulk sizes that match throughput to limit partial-container aging and repeated moisture exposure.

• Comparative footprint (general)

  • Unlike organic solvents, the environmental impact centers on energy for sterilization and cold-chain. This item ships and stores at room temperature (item-specific), avoiding refrigerated transport emissions.

• Substitution

  • There is no “greener” substitute for a compendial USP medium in regulated assays; adherence to the specified formulation is mandatory. For non-compendial research, nutritionally similar media can be evaluated for performance equivalence, but they will not replace USP-defined media in compliant testing.

Pharmaceutical Uses

Antibiotic Medium 36 (USP) is used in pharmaceutical quality control laboratories for compendial antimicrobial potency testing. No therapeutic or clinical use is implied.

• QC and compendial testing (general/USP)

  • Employed in microbiological assay methods described in the United States Pharmacopeia to determine potency of antibiotic drug substances and products by comparing microbial growth inhibition to pharmacopeial reference standards.
  • Supports method validation (accuracy, precision, linearity, robustness) and routine release/stability testing where microbiological assays are required.

• Manufacturing support (general)

  • Used for in-process controls, verification of antibiotic activity post-formulation, and batch-to-batch consistency assessments.
  • Suitable for training and qualification of analysts in compendial microbiological assay techniques (agar diffusion or turbidimetric).

• Documentation and compliance (general)

  • Ensure traceability: record lot numbers, CoAs, preparation logs, and results of growth-promotion/assay-suitability tests as required by cGMP and data integrity principles.
  • For regulated submissions, demonstrate equivalency if any procedural deviations (e.g., sterilization cycle or water type) are necessary due to local constraints.

• Excipient/formulation role

  • None. This medium is not an excipient and is not included in drug product formulations.

Note: For compendial work, always consult the current USP monograph for Antibiotic Medium 36 to confirm composition, pH, organisms, and acceptance criteria.

Physical Properties

For complex dehydrated culture media, single-compound physical constants (bp, mp, logP, etc.) do not apply. Properties below reflect general expectations for a USP antibiotic assay medium mixture.

• Item-specific properties

  • Appearance: Not specified for this item; refer to CoA/Spec Sheet. (Typically a free-flowing, tan to beige dehydrated powder—literature/general.)
  • Molecular weight: Not applicable; mixture.
  • Solubility: Freely soluble in purified/deionized water to the use concentration specified by USP (literature/general). Final clarity may be slight opalescence due to complex ingredients.
  • pH (prepared medium): Not specified for this item; refer to CoA/Spec Sheet. (Exact pH range is defined in the USP monograph—literature/regulatory.)

• Handling-relevant characteristics (literature/general)

  • Hygroscopicity: Many media components are hygroscopic; exposure to ambient humidity can cause caking and composition drift. Minimize air exposure and reseal promptly.
  • Heat response: Autoclavable. Overheating or prolonged sterilization can darken the medium (Maillard reactions between amino components and sugars, if present) and alter performance.
  • Filtration: If the formulation contains heat-labile components, sterile filtration of the prepared broth may be preferred; consult the USP procedure for the specific assay.

• Optical profile (literature/general)

  • UV/Vis absorbance is mixture-dependent and not intended for purity assessment. For potency assays by microbiological methods, growth response (zones/turbidity) is the performance criterion rather than spectroscopic properties.

Quality and Grades

• Item-specific quality information

  • Grade: BioReagent (as listed). This denotes suitability for biological research applications, with quality controls aligned to consistency in life science workflows. It does not by itself confer compendial compliance; verify against USP requirements for regulated assays.
  • Appearance, pH of prepared medium, performance (growth promotion/inhibition): Not specified for this item; refer to CoA/Spec Sheet.

• What BioReagent grade implies (general)

  • Controlled bioburden and endotoxin expectations relative to routine lab reagents, supporting reproducible microbial or cell-based assays.
  • Batch-to-batch consistency in nutrient content and solubility to minimize variability in microbial assay outcomes.

• USP context (general/regulatory)

  • “Antibiotic Medium 36 (USP)” refers to a composition and preparation defined in the United States Pharmacopeia. For regulated potency tests, verify that the lot conforms to the USP monograph specifications (e.g., formulation, pH after preparation, and performance criteria with designated test organisms). Vendors typically provide a CoA including preparation details and growth-promotion/assay suitability results where applicable.

• Stabilizers/additives

  • Not specified for this item; refer to CoA/Spec Sheet. Complex media generally do not include chemical stabilizers; stability is maintained by dry blending and moisture control.

• Recommended verification (practical)

  • Confirm pH, clarity, and growth-promotion test outcomes using the organisms defined by the relevant USP chapter before critical assays. Retain CoA and preparation records for QA documentation.

Reaction and Applications

Chemical reaction applications (e.g., synthesis, catalysis) are not applicable. This product is designed for microbiological potency testing of antibiotics following USP methods.

• Intended laboratory applications (general/USP context)

  • Microbiological assay of antibiotic potency using standardized test organisms, plates, and/or turbidimetric methods as defined in USP chapters on antimicrobial assays.
  • Quality control in pharmaceutical manufacturing to verify labeled potency of antibiotic finished products and bulk actives.
  • Method validation and system suitability testing for compendial microbial assays.

• Practical tips (general)

  • Follow the current USP monograph for Antibiotic Medium 36 exactly: medium concentration, pH, sterilization cycle, and plate/broth preparation can materially affect zone sizes or turbidity response.
  • Ensure homogenous dissolution before sterilization. Avoid localized overheating that may caramelize sugars (if present in the specific monograph) or induce Maillard reactions with peptides.
  • Perform growth-promotion/assay-suitability checks with the compendial organisms prior to routine use. Keep inoculum density, incubation temperature, and timing within USP tolerances.

• Performance considerations (general)

  • Water quality, autoclave performance, and plate thickness (for agar-based assays) are common sources of variability. Calibrate and document these parameters.
  • Use antibiotic reference standards traceable to pharmacopeial sources for calibration curves and ensure they are prepared in the diluents specified by USP.

For regulated testing, always align protocols with the current USP to ensure data acceptability.

Reaction Conditions

Chemical reaction conditions are not applicable. The relevant “conditions” pertain to media preparation and microbiological assay setup.

• Preparation conditions (general/USP)

  • Dissolve the dehydrated medium in purified water at the concentration specified by the USP monograph. Heat gently with mixing to aid dissolution if needed.
  • Sterilize according to USP guidance (commonly autoclaving); avoid excessive time/temperature to prevent medium degradation. If heat-labile components are required, add aseptically after cooling.
  • Adjust pH only if directed by the monograph, measuring at the specified temperature.

• Assay conditions (general)

  • Plate thickness (for agar diffusion assays), inoculum density, incubation temperature, and time are critical variables that determine zone diameters or turbidity curves. Calibrate and document these per USP.
  • Use pharmacopeial antibiotic reference standards to construct standard curves; prepare standards and samples in the diluents directed by USP to avoid matrix effects.

• Expected outcomes (general)

  • Growth-promotion/assay-suitability tests should meet USP acceptance criteria with designated organisms before routine potency testing proceeds.

All numerical parameters (concentrations, pH targets, sterilization cycles, inoculum levels) are defined by the USP monograph and are not specified here; consult the current pharmacopeia and the product CoA/Spec Sheet.

Safety and Handling

Follow prudent microbiology and chemical hygiene practices. This product is intended for research and laboratory use only.

• GHS/Classification (item-specific)

  • Signal word: Not specified for this item; refer to SDS.
  • H-statements: Not specified for this item; refer to SDS.
  • GHS pictograms/classification: Not specified for this item; refer to SDS.

• Potential hazards (general guidance)

  • Low inherent chemical hazard expected for typical dehydrated media; dust may cause mechanical eye/respiratory irritation. Avoid inhalation of powders.
  • Biological risk arises only after inoculation: once hydrated and inoculated, treat as biohazard per your biosafety level (BSL) guidance.

• PPE and engineering controls (general)

  • Wear lab coat, safety glasses/goggles, and appropriate gloves (e.g., nitrile). Handle powders in a fume hood or with local exhaust to minimize dust. Use a dust mask/respirator if dust generation cannot be controlled (per institutional risk assessment).

• Incompatibilities and precautions (general)

  • Avoid moisture uptake; seal promptly. Store away from strong oxidizers and acids/bases that could degrade components.
  • During sterilization, do not exceed the time/temperature specified by USP to prevent caramelization or Maillard reactions.

• First aid (overview; defer to SDS)

  • Inhalation: Move to fresh air; seek medical attention if irritation persists.
  • Eye/skin contact: Rinse with water; remove contaminated clothing.
  • Ingestion: Rinse mouth; seek medical advice if unwell.

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

Solvent Selection

This is a dehydrated microbiological medium; the relevant “solvent” is purified water. Organic solvent selection does not apply.

• Primary solvent (applicable)

  • Purified/deionized water (meets USP Purified Water or equivalent laboratory grade) for reconstitution to the concentration specified by the USP monograph (literature/regulatory).

• Practical guidance (general)

  • Use freshly prepared, oxygenated water for reproducibility. Degassing is typically unnecessary unless the USP procedure specifies it.
  • Adjust pH only if directed by the USP method; excessive acid/base can degrade medium components.
  • If heat-labile supplements are part of the USP method, add them aseptically after cooling the sterilized base medium to about hand-warm temperature (general practice; check monograph).

• Sterilization approach (general)

  • Autoclaving is standard for agar/broth bases. If the USP assay requires a sterile-filtered broth (e.g., to preserve heat-sensitive constituents), use a 0.22 μm membrane filter and aseptic technique.

• Comparison to alternatives (general)

  • Distilled vs. deionized: Either can be used if meeting purity specs; avoid water with residual disinfectants or high conductivity that may impact microbial growth.
  • Buffered water: Only use buffers if specified by the USP method; unsanctioned buffering can alter assay sensitivity.

• Not applicable

  • Miscibility, dielectric constants, and solvent polarity scales are not relevant for this product’s intended use.

Storage and Reconstitution

• Item-specific storage

  • Storage conditions: Room temperature (as listed). Keep container tightly closed. Protect from moisture; use a desiccant if available.
  • Shipped in: Normal (as listed).

• Shelf life and stability

  • Not specified for this item; refer to CoA/Spec Sheet. In general, complex media remain stable when stored dry, cool, and protected from humidity and light. Repeated exposure to ambient moisture can cause caking and performance drift.

• Reconstitution and sterilization (general)

  • Reconstitute in purified/deionized water to the concentration specified by the USP monograph for Antibiotic Medium 36. Mix until fully dissolved.
  • Sterilize according to method requirements (e.g., autoclave). Avoid prolonged heating to minimize Maillard reaction darkening and potential loss of performance.
  • If required, adjust pH only as directed by the monograph, measuring at the specified temperature.

• Post-preparation handling (general)

  • Store prepared broth or plates at temperatures recommended by institutional SOPs (often 2–8°C for short-term). Use within the validated hold time; prolonged storage can alter performance.
  • Avoid freeze–thaw of prepared agar/broth. Discard if contamination, precipitation, or significant color change is observed.

• Research use note

  • For research use only (as listed). For compendial applications, adhere strictly to USP instructions and consult the product CoA/Spec Sheet for any lot-specific preparation notes.

Structure and Identity

Antibiotic Medium 36 (USP) is a standardized, dehydrated microbiological culture medium blend defined by the United States Pharmacopeia for antimicrobial potency testing. It is a complex mixture rather than a single chemical entity.

• Item-specific identifiers

  • SKU: A1528571
  • Product name: Antibiotic Medium 36 (USP)
  • Grade/Purity: BioReagent
  • Molecular formula: Not applicable to complex media; Not specified for this item; refer to CoA/Spec Sheet.
  • Molecular weight: Not applicable to complex media; Not specified for this item; refer to CoA/Spec Sheet.
  • CAS, CID, InChIKey, SMILES: Not applicable for a multi-component medium.

• Structural features (general knowledge)

  • Complex media typically contain peptones/tryptones, yeast or meat extracts, defined salts, and—depending on the USP monograph—carbon sources and buffering agents. These components provide amino acids, peptides, vitamins, minerals, and energy to support standardized microbial growth.
  • The “structure” is a heterogeneous mixture of low- to mid-molecular-weight organics (amino acids, peptides, carbohydrates), inorganic salts, and trace growth factors; no unique 2D/3D molecular structure applies.

• Regulatory identity (general knowledge)

  • “USP Antibiotic Medium 36” denotes a composition and preparation detailed in the current USP chapter for microbial assay of antibiotics. Exact formulation and pH targets are specified in the USP monograph and must be followed for compendial testing. Consult the current USP for definitive identity and preparation details.

Synthetic Utility

Not applicable. Antibiotic Medium 36 (USP) is not a synthetic building block or reagent and is not used in chemical synthesis.

• Context (general)

  • As a complex nutrient medium, it serves to grow or sustain specific microorganisms under standardized conditions for microbiological potency assays.

• Guidance

  • For chemical synthesis or biocatalysis applications requiring defined components, use individual salts, buffers, carbon sources, and nitrogen sources in chemically defined media rather than a USP assay medium.

Target Specificity

Not applicable. This product is a microbiological culture medium, not a biological targeting reagent (e.g., antibody, ligand, inhibitor). It does not have antigen/epitope specificity, clone, isotype, or species reactivity.

• For potency assays (general/USP)
  • The “specificity” of the assay arises from the choice of test organism(s) and the antibiotic being measured, as defined by the USP method, not from the medium itself.

Foire aux questions

How should this product be stored?

Store at room temperature.