USP Standards Key Insights on Potassium Phosphate Compliance

August 3, 2026
Latest company blog about USP Standards Key Insights on Potassium Phosphate Compliance

In the fields of fine chemicals and pharmaceutical raw materials, the selection and traceability of reference standards form the cornerstone of product quality and regulatory compliance. The United States Pharmacopeia (USP), recognized globally as an authoritative standards-setting organization, provides chemical reference standards that serve as critical benchmarks for the industry. This article focuses on "Monobasic Potassium Phosphate (5 g)" from the USP Store, offering a thorough, data-driven examination to equip professionals with precise purchasing guidance and compliance insights.

Core Product Overview and Market Positioning

The subject of this analysis is USP's "Monobasic Potassium Phosphate (5 g)" (Product No. 1551139, CAS 7778-77-0, molecular formula KH₂PO₄). Categorized explicitly as a "Reference Standard," this designation underscores its primary market value—serving as an exact reference material for analytical testing, quality control, and method development. The 5-gram packaging strikes a balance between providing adequate quantity for routine laboratory use while minimizing storage challenges and potential waste associated with larger containers, reflecting a user-centric design philosophy. The premium pricing of $265.00 mirrors the value derived from its USP certification, high purity, and rigorous quality assurance protocols.

Critical Identification Parameters and Data Dimensions
1. CAS RN® 7778-77-0

This unique Chemical Abstracts Service identifier eliminates nomenclature ambiguity, ensuring accurate information transfer across databases and platforms—a vital element for data correlation and comparative analysis.

2. Molecular Formula: KH₂PO₄

The definitive chemical composition provides the foundation for understanding physical-chemical properties, reactivity, and quantitative analysis. In quality assessment, formula accuracy directly impacts content determination and impurity profiling precision.

3. Reference Standard Designation

This classification confirms compliance with USP's exacting specifications for purity, content, and impurity profiles, validating its use in method validation, instrument calibration, and sample quantification.

4. Pricing and Availability Indicators

The $265.00 price point reflects the standard's indispensable role in research, production, and quality systems. Supplementary e-commerce features including real-time inventory status ("Ready to ship"), wishlist functionality, and streamlined checkout enhance procurement efficiency for time-sensitive projects.

Batch-Specific Analysis and Traceability Framework

Current batch details (Lot R072S1) provide essential quality and compliance parameters:

Parameter Value Significance
HS Code 283524 Classifies under "Phosphates" for international trade compliance
UN Number N/A Indicates non-hazardous transport classification
NDC Number N/A Confirms reference standard (non-pharmaceutical) status
Container VIAL Sealed glass packaging ensures stability and precise measurement
Base Substance N/A Denotes 100% pure compound without matrices
Product Lifecycle and Compliance Tracking

Historical batch data reveals critical quality and supply chain patterns:

Lot Number Valid Through Origin Material Source
R072S1 (Current) Current Germany Chemical Synthesis
R072S0 31-MAY-2025 Germany Chemical Synthesis
R007B0 30-NOV-2018 United States Chemical Synthesis
F0D313 31-MAR-2015 United States Chemical Synthesis
Key Observations:
  • Expiration Management: Clear validity dating ensures proper inventory rotation and experimental reliability.
  • Geographic Transition: Production shifted from U.S. to German facilities post-R007B0, indicating supply chain optimization.
  • Quality Consistency: Persistent "Chemical Synthesis" origin across batches confirms standardized manufacturing protocols.
Regulatory and Safety Considerations

The Safety Data Sheet (SDS) provides comprehensive handling protocols for this hygroscopic compound. Notable compliance aspects include:

  • Non-hazardous transport classification (UN N/A)
  • HS code advisory noting importer/exporter verification responsibility
  • Country-of-origin determination following fundamental transformation rules
  • Special import requirement notices for biological-origin materials (non-applicable here)
Strategic Implementation Guidance

For optimal utilization of this reference material:

  1. Batch-Specific Validation: Cross-reference certificate details against application-specific purity and impurity thresholds.
  2. Regulatory Due Diligence: Independently verify HS codes and origin documentation for international shipments.
  3. Storage Protocol Adherence: Maintain sealed, moisture-controlled environments per USP specifications.
  4. Quality Tracking Systems: Implement digital batch record-keeping for audit readiness and trend analysis.

This analytical framework demonstrates how meticulous examination of standard reference materials supports robust quality systems in regulated industries.