What is USP Grade? A Methylene Blue 1% Case Study

Introduction                                                                                                                                        

You may have come across the term "USP Grade", especially for products like Methylene Blue. But what does this mean, and why is it important? In this blog, APC Pure will break down what USP Grade means in simple terms and why USP Grade Methylene Blue is a suitable choice.

What is USP Grade?

The United States Pharmacopeia (USP) is an official body that sets the standards for chemicals and other solutions. When a product is labelled as "USP Grade," it means the item has been manufactured to the guidelines set by the United States Pharmacopeia.

The USP standard is widely recognised and used in pharmaceuticals, research, and various industries to guarantee product safety, consistency, and effectiveness.

There are four USP quality guidelines followed during testing…

1. Identity

Identity testing confirms that the product is exactly what it claims to be. This ensures that the chemical composition matches its label, preventing misidentification and ensuring it is safe and effective for its intended use.

2. Potency

Ensures the concentration of the active ingredient, ensuring that the correct amount is present in the formulation.

3. Purity

Purity ensures that the product is free from contaminants, by-products, or any unwanted substances that could interfere with its intended use.

4. Performance

Performance testing ensures that the product will dissolve, mix, or react appropriately for its intended purpose.

Why does APC Pure use USP Grade MB Powder in our 1% Solution?

APC Pure uses USP Grade Methylene Blue Powder in our 1% Solution to ensure high purity and consistency among a wide variety of applications. The USP (United States Pharmacopeia) Grade means the product meets strict quality standards, making it dependable and safe for laboratory, research, and industrial use.

By using USP Grade Methylene Blue Powder, we ensure that each batch is consistent, effective, and free from unnecessary contaminants.

Specifications of APC Pure's Methylene Blue Trihydrate Powder

This information can be found on our specifications page here.

Conforms to USP Specification

Assay (Dry Basis): 98.0-103.0%
Molecular Formula: C₁₆H₁₈CIN₃S*3H₂O
Molecular Weight: 373.90
Loss on drying: 13.74%
Residue on ignition: <0.84%wt
Arsenic (As): <2.15ppm
Copper (Cu): <55ppm
Zinc (Zn): No Turbidity within 5 min

Residual Solvents

Methylene Chloride: <126 ug/g
Chloroform: <12 ug/g
Trichloroethylene: <15 ug/g
1,4-Dioxane: <49 ug/g

Mixed with our Distilled Water for our 1% Solution.

Specifications of APC Pure's Distilled Water

Chemical Analysis

Chloride (mg/L): ≤ 0.05 | Result: 0.0873 | Standard: ASTM Type 4

Sodium (mg/L): ≤ 0.05 | Result: 0.0425 | Standard: ASTM Type 4

Nitrates (µg/L): – | Result: 0.20321

Physical Analysis

Conductivity (µS/cm @ 25°C): ≤ 0.1 | Result: 0 | Standard: ISO Grade 1

Resistivity (MΩ·cm @ 25°C): ≥ 18 | Result: 18* | Standard: ASTM Type 1

pH (Water): 6.5–9.5 | Result: < 8 | Standard: WHO / UK DWI

Absorbance @ 254 nm/1 cm: ≤ 0.001 | Result: ≤ 0.0008 | Standard: ISO Grade 1

Biological Analysis

Bacteria (cfu/100 mL): ≤ 1 | Result: Not detected | Standard: ASTM Type 1

Endotoxin (EU/100 mL): ≤ 0.03 | Result: Not detected | Standard: ASTM Type 1

Where can I buy Methylene Blue 1% Solution?

APC Pure supplies Methylene Blue 1% Solution in our facility in Manchester, UK using non-toxic, chemical-resistant bottles, providing reliable and trusted quality to our customers.

It is sold in a 100ml bottle with a pipette option available for convenient dispensing.

Shop Now for Methylene Blue 1% Solution  Shop Now for Methylene Blue 1% Trihydrate USP