7-Hydroxymitragynine (Tablet)

Standard Operating Procedure (SOP)

Title: Specification and Formulation of 7-Hydroxymitragynine Tablets
Product Name: 7-Hydroxymitragynine Tablets
Strength: 50 mg per tablet

1. Purpose

To define the product specification, formulation, composition, and manufacturing standards for 7-Hydroxymitragynine Tablets, ensuring quality, safety, and compliance with Good Manufacturing Practice (GMP) requirements.

2. Scope

This SOP applies to the Research & Development, Production, Quality Assurance, and Quality Control departments involved in the manufacturing and quality control of 7-Hydroxymitragynine Tablets.

3. Formulation

Total weight per tablet: 50 mg

Component	Amount per tablet (mg)	Remarks
7-Hydroxymitragynine (20% extract)	15 mg	Active pharmaceutical ingredient
Pseudoindoxyl	5 mg	Active pharmaceutical ingredient
Excipients	30 mg	Fillers, binders, disintegrants, lubricants, etc., as per GMP

4. Excipients

The excipients shall include approved pharmaceutical-grade substances such as:

Microcrystalline Cellulose (filler)
Lactose Monohydrate (filler)
Povidone K30 (binder)
Croscarmellose Sodium (disintegrant)
Magnesium Stearate (lubricant)

The type and quantity of excipients shall be determined according to the final validated formulation and stability data.

5. Product Characteristics

Dosage form: Compressed tablet
Color: White or as per approved colorant safe for human consumption
Weight: 50 mg per tablet
Route of administration: Oral, as directed by a licensed physician

6. Product Quality Requirements

Weight variation: ±5%
Content uniformity: 90%–110% of label claim
Disintegration time: Within 30 minutes
Moisture content: Not more than 5%

7. Quality Control Measures

Manufactured in compliance with GMP standards
Raw materials, in-process materials, and finished products must undergo inspection and testing as per approved specifications
Stability testing shall be conducted according to an approved stability protocol

8. Storage Conditions

Store in a tightly closed container, protected from light and moisture, at 25°C ± 2°C.

9. Directions for Use

To be used only under the supervision of a licensed physician and pharmacist.

Conditions are as follows:
1. Accept to produce tablets according to purchase orders and ODM production contracts.
2. Production standards according to the standards of pharmaceutical factories certified by law.