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Methylene Blue Capsules for Oral Formulations

Methylene Blue Capsules for Oral Formulations

  • $85

    1-199 Others

  • $80

    200-499 Others

  • $75

    ≥500 Others

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Product Attributes

Product Description

Product Overview

Methylene Blue Capsules are oral solid-dose formulations containing methylene blue, a synthetic phenothiazine compound used in pharmaceutical and laboratory applications. For B2B buyers, capsule production requires control of active identity, assay, capsule fill uniformity, packaging, and target-market regulatory requirements for the finished product.

Methylene blue is commonly supplied as a chloride salt and is recognized by its intense blue color. In Capsule Manufacturing, the active ingredient is combined with suitable pharmaceutical excipients according to the intended formulation, dosage form, stability requirements, and applicable regulatory framework.

What Is Methylene Blue?

Methylene blue, also known as methylthioninium chloride, is a phenothiazine compound with the molecular formula C16H18ClN3S and a molecular weight of 319.85 g/mol for the anhydrous chloride form. It is typically encountered as a dark blue to blue crystalline powder and is readily identifiable by its characteristic color.

Methylene blue has established pharmaceutical and laboratory uses. Its regulatory status, permitted indications, dosage requirements, and suitability for oral products vary by jurisdiction. Finished capsule specifications should therefore be developed according to the intended market rather than treating a laboratory-grade material as automatically suitable for human consumption.

Specifications

Item Specification
Product Name Methylene Blue Capsules
Active Ingredient Methylene Blue (Methylthioninium Chloride)
CAS Number 61-73-4 for anhydrous methylene blue chloride; hydrate forms may have different CAS numbers
Molecular Formula C16H18ClN3S
Molecular Weight 319.85 g/mol
Typical Appearance Dark blue to blue crystalline powder for the active ingredient; finished capsules vary according to shell and formulation
Assay / Active Content Commonly specified by active methylene blue content; capsule strength can be customized according to formulation and applicable regulatory requirements
Test Method Identity and assay by validated chromatographic or spectrophotometric methods, as applicable to the specification
Dosage Form Hard capsule
Capsule Shell Standard hard capsule options; shell material and color can be customized
Excipients Selected according to formulation, stability, flowability, capsule-fill requirements, and target-market regulations
Particle Size Customizable to formulation and manufacturing requirements
Shelf Life Commonly up to 24 months when appropriately packaged and stored; final shelf life should be supported by product-specific stability data
Storage Store in a cool, dry place, protected from moisture, excessive heat, and direct sunlight
Packaging HDPE bottles, blister packs, or other suitable pharmaceutical packaging; bulk packaging and custom labeling available
Documentation COA, TDS, SDS, and relevant quality documentation available according to product and market requirements

Key Product Characteristics

  • Defined active identity: Methylene blue can be verified through appropriate analytical identification testing.
  • Assay-focused quality control: Active content is an important incoming-material and finished-product specification.
  • Capsule formulation flexibility: Capsule shell, fill weight, excipient system, and packaging can be adapted to the intended product design.
  • Finished-product consistency: Capsule weight variation and content uniformity are important considerations for oral solid-dose manufacturing.
  • Regulatory awareness: Finished-product claims, dosage, labeling, and marketability require review against the regulations of the destination market.

Applications

Methylene blue capsules are developed primarily as finished oral dosage products where an encapsulated form is appropriate under the applicable regulatory framework. Potential B2B applications include pharmaceutical product development, regulated oral formulations, private-label projects where legally permitted, and custom capsule manufacturing programs.

Because methylene blue has established medical uses and its legal status differs between markets, buyers should define the intended regulatory category before selecting the active specification, capsule strength, claims, and label language.

Buyer Decision Guide: Active Specification Matters Before Capsule Production

For methylene blue capsules, the first procurement decision should be the identity and specification of the active material rather than simply the capsule size. Methylene blue chloride can occur in different physical forms, including anhydrous and hydrate forms, and the corresponding molecular weight and analytical basis can differ. The supplier specification and finished-product calculation should therefore use one clearly defined material identity.

Buyer Requirement What to Control Why It Matters
Active identity Methylene blue chemical identity, salt/form, CAS reference, and identification method Prevents calculation and analytical discrepancies between the raw material specification and finished capsule
Assay Defined assay basis and validated test method Provides a consistent basis for raw-material release and finished-product specifications
Capsule strength Active content per capsule and acceptable manufacturing tolerances Determines formulation design, fill composition, and content-uniformity requirements
Finished-product quality Appearance, average fill weight, weight variation, content uniformity, and relevant microbiological controls Supports consistent production and incoming inspection of finished capsules
Target market Permitted use, dosage, claims, labeling, and registration requirements Methylene blue is subject to market-specific regulatory controls, so a formulation suitable for one market may not be suitable for another

OEM & Private Label

Custom capsule manufacturing can cover formulation development, capsule-shell selection, filling, packaging, labeling, and private-label production. Capsule strength, excipient selection, packaging format, label design, and batch size can be adapted to the project requirements.

For commercial projects, the manufacturing specification should be finalized around the target market, intended regulatory category, active-material specification, and required quality documentation. Bulk quantities and customized packaging formats can be supported according to production requirements.

Quality Control

Quality control for methylene blue capsules should address both the active ingredient and the finished dosage form. A comprehensive quality program can include:

  • Identity verification of methylene blue
  • Purity and assay testing
  • Heavy metals analysis where applicable
  • Microbiological testing
  • Residual solvent testing where applicable
  • Moisture content verification
  • Capsule weight and physical inspection
  • Finished-product content uniformity testing according to the applicable specification

Products can be manufactured under GMP-standard conditions with in-house R&D and testing support. Third-party testing and certifications can be arranged where relevant to the product and target market.

Packaging Options

Methylene blue capsules can be supplied in standard retail-ready or bulk formats, including HDPE bottles and blister packaging. Outer cartons, labels, capsule colors, and packaging configurations can be customized for private-label projects. Packaging should provide appropriate protection from moisture, light, and other environmental factors relevant to product stability.

Why Choose This Product

  • Defined methylene blue active specification for controlled formulation development
  • Flexible capsule and packaging configurations
  • Support for custom formulation and private-label projects
  • Per-batch quality testing for identity, assay, and relevant safety parameters
  • Technical documentation including COA, TDS, and SDS according to project requirements
  • Stable bulk production capability and global export experience

Regulatory and Labeling Considerations

Methylene blue should not be marketed with unsupported disease-treatment, disease-prevention, or guaranteed health claims. Its permitted use, dosage, labeling, and regulatory classification can differ substantially by country or region. Buyers should complete target-market regulatory review before commercial launch and ensure that the finished formulation and label comply with applicable requirements.

Conclusion

Methylene Blue Capsules provide a convenient oral solid dosage format for appropriately regulated product-development and pharmaceutical applications. Reliable sourcing depends on clearly defining the active material form, assay basis, capsule strength, finished-product controls, packaging, and destination-market requirements.

Contact us today to request samples, a COA, technical documents, and a wholesale quotation for Methylene Blue Capsules.

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