Antibiotic Medium 5 (USP) - BioReagent

Cat. No.: A1528616

GRADE & PURITY BioReagent

Storage

Room temperature

Shipped In

Normal

Overview

For microbiological assay of antibiotic potency. Preparation method: Weigh 25.5 g of this product in 1 L of distilled or deionized water (the volume may be scaled up or down proportionally), heat to boiling 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 of the vessel, then set aside for use.

Specifications

Specifications & Purity

BioReagent

Storage

Room temperature

Shipped In

Normal

Grade

BioReagent

Product Line

biological_products

Application Protocols

The exact preparation parameters (mass per liter, pH targets, cycle times) are Not specified for this item; refer to the product label/CoA and the current USP monograph for Antibiotic Medium 5. The following is general, literature-based guidance for compendial antibiotic assays:

• Preparation (broth or agar):

  • Weigh the prescribed amount of dehydrated medium. Suspend in purified water with stirring. Heat gently to dissolve. If agar plates are required, include the specified agar concentration before sterilization.
  • Adjust pH as required by the antibiotic’s USP method. Dispense into appropriate vessels (flasks, tubes, or bottles) for autoclaving.
  • Sterilize using a validated autoclave cycle suitable for the fill volume. Cool to ~45–50 C for plate pouring under aseptic conditions, or to room temperature for broth use.

• Assay setup (agar diffusion):

  • Prepare a uniform lawn of the specified test organism using a standardized inoculum.
  • Apply reference standard and sample solutions to cylinders or wells on set plate thickness. Incubate under prescribed conditions. Measure inhibition zones and construct a standard curve to calculate potency.

• Assay setup (turbidimetric):

  • Inoculate broth with standardized inoculum. Add graded concentrations of antibiotic standard and test sample. Incubate with controlled aeration/temperature. Measure turbidity (e.g., OD) and determine activity from the standard response curve.

• Quality controls:

  • Perform growth-promotion/inhibition suitability tests, include blanks and standards, and document all critical parameters (pH, temperature, times, plate thickness).

For regulated testing, follow USP instructions verbatim and your laboratory’s validated SOPs.

Biological Roles

• Nature of product:

  • A nutrient medium supporting growth of designated test microorganisms for antibiotic potency assays. It provides carbon, nitrogen, vitamins, and minerals that enable reproducible microbial proliferation under assay conditions.

• Functional context (general/literature):

  • Balanced peptones/tryptones supply amino acids and peptides; yeast/beef extracts contribute growth factors (e.g., B-vitamins); carbohydrate(s) supply energy; salts maintain osmotic balance and contribute buffering. The precise composition and concentrations are defined by pharmacopeial monographs and manufacturer specifications.
  • In antibiotic assays, the medium must promote adequate baseline growth of the indicator organism while allowing differential inhibition by the antibiotic under test, translating into quantifiable zones (agar diffusion) or turbidity changes (broth methods).

• Biological performance considerations:

  • pH and ionic composition modulate antibiotic activity (e.g., aminoglycosides vs. divalent cations) and microbial growth rates. Maintain the specified pH and preparation protocol for the target antibiotic.
  • Medium age and storage conditions influence vitamin stability and redox potential, affecting organism responsiveness. Use freshly prepared media within validated hold times.
  • For diffusion assays, agar concentration and gel strength affect molecular diffusion and thus zone diameters; follow compendial thickness specifications.

• Limitations:

  • Not intended to sustain fastidious organisms unless supplemented as directed by the assay method.
  • For research/QC use only; not for clinical diagnostics (per Product Data).

Buffer Applications

This product is not primarily a buffer system; it is a complex nutrient medium. However, pH control and buffering capacity are integral to its performance in antibiotic assays.

• General guidance (literature/practice):

  • Target pH ranges and adjustment procedures are specified in the pharmacopeial method for each antibiotic under test. Use acid/base solutions standardized for microbiological media (e.g., sterile 1 N HCl/NaOH) and verify pH at room temperature after sterilization (or according to the method’s instruction).
  • Excessive buffering can alter antibiotic ionization and activity; do not substitute buffers or add unprescribed salts without revalidation.
  • If the method requires supplemental buffering (e.g., phosphate), prepare and sterilize buffers separately if heat-labile components are involved, then aseptically combine.

• Practical tips:

  • Calibrate pH meters with buffers bracketing the target pH and measure under the same temperature conditions as the assay, as pH is temperature dependent.
  • Record pre- and post-sterilization pH to monitor drift; minor adjustments may be necessary within the permitted range.

• Item-specific buffer specifications:

  • Not specified for this item; refer to CoA/Spec Sheet and the applicable USP monograph for the antibiotic being assayed.

Green Alternatives

For culture media used in microbiological assays, “green chemistry” considerations focus on waste minimization, energy use during sterilization, and responsible sourcing rather than solvent substitution.

• Opportunities (general):

  • Batch sizing: Prepare only the volume needed to reduce discard of expired plates/broth.
  • Energy efficiency: Optimize autoclave loads (full loads, validated cycles) and use insulated transport/storage to limit re-melts. Consider validated fractional sterilization or sterile filtration for heat-labile additives to avoid repeated autoclaving.
  • Water stewardship: Use high-purity water efficiently; capture cool-down water from autoclaves where facility policy allows.
  • Packaging: Select pack sizes that match usage to minimize partial-container exposure and waste; recycle packaging where possible.

• Trade-offs (general):

  • Lower sterilization temperatures or shorter cycles may conserve energy but must not compromise sterility or performance; always validate cycles per lab QA/QC.
  • Some “ready-to-use” media can reduce on-site energy use but may increase shipping weight/volume and cold-chain impacts.

• Comparison snapshot (general):

  • Dehydrated medium (this item): Lower shipping mass/volume; user controls preparation; requires autoclave energy on site.
  • Ready-poured plates/broth: No on-site prep; higher transport footprint; potential for shorter shelf-life.

Choose practices that meet your quality system while minimizing environmental impact, and document any changes through method suitability testing.

Pharmaceutical Uses

• Intended role (general/industry practice):

  • Use in quality control laboratories for compendial microbiological assays of antibiotic potency/content as described in USP/Ph. Eur. This includes method development, suitability testing, routine lot release, and stability study support for antibiotic products.

• Relevance to regulated testing:

  • Pharmacopeial media selections are prescriptive; Antibiotic Medium 5 (USP) should be used where specified by the monograph or general chapter to ensure method equivalence. Deviations require method revalidation or verification per regulatory guidance.

• Excipient/formulation status:

  • Not used as a pharmaceutical excipient; it is a laboratory culture medium.

• Documentation and compliance:

  • Maintain CoA, preparation logs (lot numbers, weights, water quality, pH, sterilization cycle), sterility checks, and growth-promotion/inhibition test records.
  • Implement change control for any modifications (e.g., alternative water source, autoclave cycle changes, supplier changes) and perform method suitability as required.

• Item-specific regulatory notes:

  • No specific pharmacopeial certification is stated in Product Data. Users are responsible for confirming suitability against the current USP monograph.

• Research Use Note (Product Data):

  • For research use only. Not for use in diagnostic procedures or therapeutic applications.

Physical Properties

Because this product is a complex dehydrated culture medium blend, conventional single-compound physical constants do not apply.

• Item-specific (Product Data):

  • Appearance: Not specified for this item; refer to CoA/Spec Sheet.
  • Molecular Weight: Not specified for this item; refer to CoA/Spec Sheet.

• Typical attributes upon receipt (general/literature):

  • Physical form: Free-flowing dehydrated powder; hygroscopic behavior is common for media blends.
  • Color: Usually light tan to beige; minor lot-to-lot variation is normal due to natural raw materials.
  • Odor: Mild, characteristic of peptone/yeast extracts.

• Reconstituted medium (general/literature values; not item-specific specs):

  • Solvent: Purified/deionized water.
  • Clarity: Clear to slightly opalescent after dissolution and sterilization (broth); translucent gel when prepared as agar plates (if agar is included/added per method).
  • pH after preparation: Typically specified by pharmacopeial method for the antibiotic under test; verify and adjust per USP monograph. Exact target pH: Not specified for this item; refer to CoA/Spec Sheet.
  • Osmolality/ionic strength: Depends on formula; monitor if critical to assay performance.

• Stability considerations (general):

  • Dry powder is moisture sensitive; caking may indicate humidity exposure.
  • Prepared media are perishable; shelf-life depends on storage temperature, sterility, and light exposure.

Always consult the product’s CoA/Spec Sheet and current USP chapter <81> (or applicable) for quantitative preparation parameters.

Quality and Grades

• Item-specific (Product Data):

  • Grade/Purity: BioReagent.

• What BioReagent grade typically implies (general/industry usage):

  • Suitable for biological/biochemical applications, manufactured with attention to microbial and chemical quality appropriate for laboratory life-science workflows.
  • Focus on consistency of nutrient profile and performance in biological assays, rather than analytical trace-metal specifications.

• USP context (general):

  • The designation “Antibiotic Medium 5 (USP)” indicates intended alignment with a pharmacopeial medium used in antibiotic assay procedures. For regulated QC, users should verify compliance with the current USP monograph (e.g., composition, pH, performance testing with defined test organisms and antibiotics).

• Lot release and performance (recommendations):

  • Review the Certificate of Analysis (CoA) for: appearance, moisture content (if provided), pH of prepared medium, sterility, and growth-promotion/inhibitory characteristics with specified strains (per USP/Ph. Eur.).
  • Perform incoming qualification using compendial organisms and assay endpoints relevant to your method (e.g., zone diameters in cylinder-plate tests, turbidity response in turbidimetric assays).

• Stabilizers/indicators:

  • Not specified for this item; refer to CoA/Spec Sheet for any included indicators (e.g., dyes), agar content, or supplements.

• Documentation:

  • Retain CoA, SDS, and preparation records. For GMP/QC use, align with internal SOPs and pharmacopeial verification requirements.

Reaction and Applications

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

• Core applications (general/literature for USP AM5):

  • Antibiotic potency testing by agar diffusion (cylinder-plate) or turbidimetric (broth) assays under USP chapters governing microbiological assays of antibiotics.
  • Preparation of seeded agar layers or broth tubes standardized for specific test organisms to quantify activity of antibiotics via zones of inhibition or growth response.
  • Method qualification/verification for QC of antibiotic products, including linearity, accuracy, and precision assessments using pharmacopeial strains.

• Practical considerations (general):

  • Use standardized inoculum densities (e.g., matched to a turbidity standard) prepared from fresh cultures of compendial organisms; verify growth-promotion and inhibitory characteristics as prescribed.
  • pH control is critical because antibiotic activity can be pH dependent. Adjust medium pH only within ranges specified by the monograph for the antibiotic under test.
  • Ionic content and divalent cations can modulate antibiotic activity; avoid unverified supplements or water sources that change ionic strength.
  • For agar diffusion, plate thickness and agar concentration influence diffusion and zone sizes—maintain consistent pour volumes and solidification conditions.

• Noteworthy limitations:

  • Not intended for clinical diagnosis or patient sample testing. For research/QC use only (per Product Data).
  • Do not substitute other media without revalidating the assay, as differences in nutrient composition can bias potency results.

Reaction Conditions

Not applicable in the context of chemical reactions. However, successful microbiological assays using this medium depend on controlled preparation conditions (general/literature guidance):

• Water quality: Use high-purity water (USP/ASTM Type I or II) to avoid ionic and organic contaminants that can affect antibiotic activity.
• Dissolution: Add medium gradually to water with stirring to prevent clumping; gentle heating may aid dissolution.
• Sterilization: Autoclave using a validated cycle appropriate for the filled volume (e.g., 121 C, saturated steam; exact time depends on volume). Specific parameters are Not specified for this item; refer to CoA/Spec Sheet and facility SOPs.
• pH: Adjust per the pharmacopeial method for the antibiotic under test; verify after sterilization if required.
• Inoculation: Standardize inoculum density (e.g., McFarland standards) using compendial strains; incubate at prescribed temperatures/times.

These are general microbiological conditions and not item-specific specifications.

Safety and Handling

• Item-specific (Product Data):

  • Storage Conditions: Room temperature.
  • Shipped In: Normal.
  • GHS Classification, Signal Word, H-Statements, Pictograms: Not specified for this item; refer to SDS.

• General safety guidance (dehydrated culture media; literature/practice):

  • Avoid inhalation of dust; fine particulates can cause respiratory irritation. Handle in a fume hood or with local exhaust when weighing.
  • Prevent moisture uptake; keep containers tightly closed with desiccant to avoid microbial growth in the container.
  • After hydration/sterilization, treat as microbiological material. Maintain aseptic technique to prevent contamination.
  • PPE: Lab coat, safety glasses, and suitable gloves (e.g., nitrile). Use a dust mask/respirator if dust generation is unavoidable and engineering controls are insufficient.

• Incompatibilities and conditions to avoid (general):

  • Strong oxidizers may react with organic components.
  • Excess humidity and prolonged light/heat can degrade nutrients (e.g., vitamins) and alter medium performance.

• First-aid overview (general):

  • Inhalation: Move to fresh air; seek medical guidance if irritation persists.
  • Skin contact: Wash with soap and water; remove contaminated clothing.
  • Eye contact: Rinse cautiously with water for several minutes; remove contact lenses if present and easy; obtain medical attention if irritation continues.
  • Ingestion: Rinse mouth; seek medical advice.

For authoritative hazard information, consult the product’s SDS and institutional biosafety procedures.

Solvent Selection

This product is a culture medium and is intended to be dissolved in water; organic solvent selection is not applicable.

• Reconstitution solvent (item-specific vs. general):

  • Item-specific: Required solvent and mass-per-liter are Not specified for this item; refer to CoA/Spec Sheet/label.
  • General (literature/practice): Use purified/deionized water meeting USP or ASTM Type I/II specifications. Dissolve with gentle warming and agitation. Adjust pH if required by the target antibiotic assay, then sterilize (typically by autoclaving) unless using sterile-filtered methods appropriate for heat-labile supplements.

• Practical tips (general):

  • Avoid high-temperature or prolonged heating before autoclaving; excessive heat can degrade vitamins and carbohydrates.
  • If preparing agar plates, add the appropriate agar concentration before sterilization, dissolve completely by heating, then pour at ~45–50 C under aseptic conditions.
  • Degassing is generally unnecessary; avoid vigorous aeration that can cause foaming and pH drift.

• When to choose this medium vs. alternatives (general):

  • Select Antibiotic Medium 5 (USP) when following USP antibiotic potency assays requiring AM5. Use the exact medium specified by the monograph for the antibiotic under test. If a different USP antibiotic medium (e.g., AM1, AM2, AM11) is prescribed, use that specific formulation to ensure method suitability.

• Compatibility:

  • Designed for aqueous systems; not miscible with or intended for organic solvents.

Storage and Reconstitution

• Item-specific (Product Data):

  • Storage Conditions (dry powder): Room temperature.
  • Shipped In: Normal.

• Storage recommendations (general/best practice):

  • Keep container tightly closed in a cool, dry place. Protect from humidity and direct light. Use desiccant and minimize container open time to prevent caking and moisture uptake.
  • Observe manufacturer’s retest or expiration date; record opening date and store aliquots if frequent access is expected.

• Reconstitution (general; not item-specific specs):

  • Use purified/deionized water. Suspend the specified mass of dehydrated medium per liter (amount Not specified for this item; refer to CoA/Spec Sheet/label). Mix thoroughly; gentle heating may be used to aid dissolution.
  • Adjust pH if required by the applicable USP method for the antibiotic under test.
  • Sterilize by autoclaving using a validated cycle appropriate for the container size and fill volume. Do not overheat or hold at high temperature longer than necessary.

• Post-preparation handling (general):

  • Broth: Store at 2–8 C if not used immediately; use within validated hold times.
  • Agar plates: Dry plates as needed to remove surface moisture; store inverted in sealed sleeves at 2–8 C, protected from light; equilibrate to room temperature before use.
  • Avoid repeated freeze-thaw; freezing is generally not recommended for prepared complex media unless validated.

• Disposal:

  • Decontaminate used media by autoclaving or appropriate disinfectants before disposal, per institutional biosafety procedures.

Always defer to the product’s CoA/Spec Sheet and your laboratory SOPs for exact quantities, pH targets, and expiration/hold times.

Structure and Identity

Antibiotic Medium 5 (USP) is a defined microbiological growth medium per United States Pharmacopeia (USP) intended for antibiotic potency testing. It is a formulated blend (typically dehydrated powder) rather than a single chemical entity, so small-molecule identifiers do not apply.

• Item-specific (Product Data):

  • Product Name: Antibiotic Medium 5 (USP)
  • SKU: A1528616
  • Grade/Purity: BioReagent
  • CAS, CID, SMILES, InChIKey, Molecular Formula, Molecular Weight: Not specified for this item; refer to CoA/Spec Sheet.

• Identity context (general/literature):

  • Also known as “USP Antibiotic Medium No. 5 (AM5).”
  • Intended for microbiological assay of antibiotics by cylinder-plate (agar diffusion) and/or turbidimetric methods as described in pharmacopeial procedures (USP/Ph. Eur.).
  • Typically supplied as a homogeneous tan-to-beige dehydrated powder containing balanced nutrients (peptones/tryptones, yeast/beef extracts, carbohydrates, mineral salts; exact composition per monograph/manufacturer). No discrete 2D small-molecule structure exists.

• Structural features (conceptual):

  • Complex, multicomponent mixture of biogenic macromolecular fragments (peptides, amino acids), vitamins, and salts forming a buffered nutrient matrix upon dissolution and sterilization.

• Conformity:

  • “USP” in the name indicates intended use aligns with pharmacopeial methods; end-user verification against the current USP monograph is recommended for regulated testing.

Synthetic Utility

Not applicable. Antibiotic Medium 5 (USP) is a microbiological growth medium, not a synthetic organic/inorganic reagent. It is not used as a building block, catalyst, or solvent in chemical synthesis. For relevant information, see Reaction & Applications and Application Protocols for microbiological assay workflows.

Target Specificity

Not applicable. This product is not an antibody, probe, or targeted biochemical. It is a general-purpose microbiological medium formulated for antibiotic assay procedures and does not exhibit molecular target specificity. Any selectivity arises from the interaction between the test organism, the antibiotic under test, and assay parameters defined by pharmacopeial methods.