Dibasic Potassium Phosphate USP: Specifications, Quality Parameters for Pharmaceutical

Kapil Radadiya
Written by Kapil Radadiya
Dibasic Potassium Phosphate USP: Specifications, Quality Parameters for  Pharmaceutical

Inorganic phosphate salt of pharmaceutical grade is called Dibasic Potassium Phosphate USP. The major function of the compound is the preparation of buffers and pH adjustment. However, the compound is also used by manufacturers during pharmaceutical manufacturing and formulation of certain medicines. Alternative names include Potassium Phosphate Dibasic and K2HPO4.

The name USP indicates that the material meets the requirements of the appropriate version of the United States Pharmacopeia-National Formulary.

The molecular formula for Dibasic Potassium Phosphate is K₂HPO₄, and its CAS number is 7758-11-4, with a molecular weight of 174.18 g/mol. The substance is described by PubChem as an extremely soluble dipotassium phosphate salt.

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However, the term “USP grade” should not be used merely as a marketing phrase. Instead, it should only be applied when the material has been tested, verified, and documented in accordance with the current applicable USP standards.

What Is the Meaning of USP Grade?

USP is an acronym for United States Pharmacopeia, which sets public standards for drugs, excipients, dietary supplements, and other related materials.

When a company describes its product as Dibasic Potassium Phosphate USP grade, the company should test the material according to the applicable official USP–NF monograph. In addition, the company should support the claim with an approved specification, validated or verified test methods, and a batch-specific Certificate of Analysis. Therefore, buyers should review the supporting quality documents before approving the material for pharmaceutical use.

Chemical Identity

Dibasic Potassium Phosphate is the dipotassium salt of phosphoric acid.

The chemical formula for this compound is: K₂HPO₄

Some of the other names that can be used for it are:

  • Dibasic Potassium Phosphate
  • Potassium Phosphate Dibasic
  • Dipotassium Hydrogen Phosphate
  • Dipotassium Phosphate
  • Dipotassium Hydrogen Orthophosphate

In addition, the U.S. Food and Drug Administration (FDA) includes Dibasic Potassium Phosphate in its list of food substances under CAS No. 7758-11-4. The FDA also recognizes the alternative names Potassium Phosphate Dibasic and Dipotassium Hydrogen Phosphate.

Use of both the CAS number, molecular formula and proper name prevents

DIBASIC POTASSIUM PHOSPHATE USP SPECIIFCATION

TESTSPECIFICATION
DescriptionWhite or colourless crystalline powder or granules
Identification Test
A) PotassiumIt gives reaction of Potassium.
B) Phosphate It gives reaction of Phosphate.
Insoluble substancesNot more than 0.2%
CarbonatePass the test
ChlorideNot more than 0.03%
SulphateNot more than 0.1%
ArsenicNot more than 3 ppm
IronNot more than 30 ppm
SodiumPass the test
FluorideNot more than 0.001%
Monobasic or Tribasic saltPass the test
pH8.59.6
Loss on dryingNot more than 1.0%
Assay on the dried basis98.5% – 100.5%
Packing and storage of Dibasic Potassium Phosphate USP: Preserve in well-closed containers.

DIBASIC POTASSIUM PHOSPHATE USP SPECIFICATION

Supplier Selection Guidance for Dibasic Potassium Phosphate USP

Price considerations must not be the only thing procurement and quality consider.

Verify the Grade

Ensure that the grade is consistent across the quote, specification, label, and COA.

Analyze the Specification

Cross-check the specification from your supplier against:

  • Latest USP specification
  • Internal raw material specification
  • Development needs
  • Destination market requirements
  • Analyze Batch Results

Do not base decisions on standard specifications alone. Analyze the COA values for the offered batch.

Evaluate the Quality System

  • Supplier qualifications
  • Deviation management
  • Change management process
  • Complaint handling
  • Lot traceability
  • Recall process
  • Data integrity
  • Document management
  • Assess Supply Reliability

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FAQs

What is Dibasic Potassium Phosphate USP?

Pharmaceutical-grade Potassium Phosphate Dibasic that meets all appropriate current USP standards.

What is the formula of Dibasic Potassium Phosphate?

K₂HPO₄

What is the CAS number?

CAS Registry Number is 7758-11-4.

Is Potassium Phosphate Dibasic USP the same as Dibasic Potassium Phosphate USP?

Yes. Both grades refer to the same chemical compound.

Is Dipotassium Hydrogen Phosphate the same compound?

Yes. Dipotassium Hydrogen Phosphate is another name of K₂HPO₄.

What is Dibasic Potassium Phosphate USP for?

It is usually used for buffer preparations, pH adjustment, pharmaceutical applications, laboratory reagents and biotechnology.

What is the difference between USP and food grade?

USP grade is evaluated against applicable pharmaceutical compendial requirements. Food grade is evaluated against relevant food regulations or food-grade specifications. The two designations are not interchangeable.

What documents can Chemignition Laboratory provide?

Depending on the approved product and customer requirement, documentation may include a COA, SDS, TDS, specification and relevant quality or regulatory declarations.