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Minoxidil API USP/BP/Ph.Eur./IP (38304-91-5)

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What is Minoxidil?

Minoxidil (2,4-diamino-6-piperidinopyrimidine 3-oxide), a pyrimidine N-oxide, often known as Rogaine, is a pharmaceutical compound widely used for the treatment of hair loss and severe refractory hypertension. Initially developed as an oral medication for high blood pressure, Minoxidil is now widely used to treat androgenetic alopecia (male and female pattern hair loss) and promote hair regrowth.

Minoxidil is the active ingredient in FDA-approved topical hair regrowth formulations, including solutions and foams applied directly to the scalp. It works by stimulating hair follicles, promoting hair growth and slowing hair loss. Along with its dermatological applications, oral Minoxidil is prescribed for severe resistant hypertension. As a potent vasodilator, it relaxes blood vessels, improves blood flow and helps lower blood pressure.

Macsen Labs is a manufacturer and supplier of high-quality Minoxidil USP/Ph.Eur./BP/IP(CAS 38304-91-5), a pharmaceutical-grade API used in hair loss treatments and oral pharmaceutical formulations.We cater to all grades of Minoxidil, including Minoxidil IP, Minoxidil BP, Minoxidil EP, and Minoxidil USP, to meet the growing demand from both domestic and international pharmaceutical markets.
PRODUCT SPECIFICATIONS
Name of Product Minoxidil
IUPAC Name 3-Hydroxy-2-imino-6-(piperidin-1-yl)pyrimidin-4-amine
Synonyms Rogaine, Loniten, Regaine
CAS No 38304-91-5
Molecular Formula C9H15N5O
Molecular Weight 209.25 g/mol
Grades USP, IP, BP, Ph. Eur.
GMP ✓
DMF Under compilation
EU-WC Available soon
US-DMF Available soon

Minoxidil USP-TECHNICAL SPECIFICATIONS

S. No. Test Parameter Minoxidil USP
1 Appearance White to off-white crystalline powder
2 Solubility Soluble in alcohol and propylene glycol; sparingly soluble in methanol; slightly soluble in water; practically insoluble in chloroform, acetone, ethyl acetate and hexane.
3 Identification - IR IR spectrum concordant with Minoxidil working standard
4 Assay by HPLC (dried basis) NLT 97.0% and NMT 103.0%
5 Residue on Ignition NMT 0.5%
6 Loss on Drying NMT 0.5%
7 Organic Impurities by HPLC / Related Substance NMT 1.5%
8 Residual Solvent - Methanol NMT 3000 ppm
9 Residual Solvent - Piperidine NMT 1000 ppm

Download detailed Minoxidil specification sheets:

Minoxidil Ph. Eur.  |  Minoxidil IP

How does Minoxidil work?

Minoxidil promotes hair growth by opening ATP-sensitive potassium (KATP) channels, regulating hair follicle activity, and stimulating growth-related signaling pathways. Although its exact mechanism remains under investigation, research suggests several key actions:

  • Potassium Channel Activation: Minoxidil activates KATP channels, including Kir6/SUR2 channels, causing cell membrane hyperpolarization and supporting hair follicle activity.

  • Improved Blood Circulation: Minoxidil acts as a vasodilator, relaxing blood vessels and potentially improving oxygen and nutrient delivery to hair follicles.

  • Hair Growth Cycle Regulation: Minoxidil encourages follicles to transition from the resting (telogen) phase to the active growth (anagen) phase, which may cause temporary initial shedding.

  • Adenosine Signaling: Minoxidil may influence adenosine-mediated signaling pathways, supporting dermal papilla cell activity and hair growth.

  • Growth Factor Stimulation: Minoxidil may increase growth factors such as VEGF, HGF, and IGF-1, which play roles in follicular growth and maintenance.

  • Blood Pressure Reduction: When used as an oral vasodilator, minoxidil relaxes vascular smooth muscle, widening blood vessels and reducing blood pressure.

Together, these mechanisms help explain how minoxidil stimulates hair regrowth and improves hair density, although their individual contributions are not fully established.

Uses of Minoxidil

  • Hair Loss Treatment: Minoxidil is widely used in topical formulations, including solutions and foams, to treat hair loss and promote hair regrowth.
  • Androgenetic Alopecia: Minoxidil helps stimulate hair growth in men and women affected by androgenetic alopecia (pattern hair loss).
  • Hair Growth Maintenance: Consistent use of topical Minoxidil helps maintain hair regrowth and slow further hair loss.
  • Severe Hypertension: Oral Minoxidil is used to treat severe resistant hypertension when other antihypertensive medications are ineffective.

Side Effects of Minoxidil

  • Scalp Irritation: Topical Minoxidil is generally well tolerated but may cause itching, redness, dryness, burning or irritation of the scalp.
  • Unwanted Hair Growth: Minoxidil may cause excessive hair growth (hypertrichosis) on the face or other areas of the body.
  • Temporary Hair Shedding: Some users may experience increased hair shedding during the initial weeks of treatment as hair follicles transition through the growth cycle.
  • Allergic Reactions: Rare reactions may include skin rashes, severe itching, facial swelling or difficulty breathing.
  • Cardiovascular Side Effects: Rare systemic effects of topical Minoxidil may include dizziness, rapid heartbeat (tachycardia), chest discomfort, sudden weight gain or swelling of the hands and feet. These effects are more relevant to oral Minoxidil therapy.
  • Headache and Dizziness: Some individuals experience headaches or dizziness during Minoxidil treatment.

FAQs

Q. Is Minoxidil safe?

Minoxidil is a medicine for hair loss in men and women that has been approved by Health Canada and the US FDA. Topical preparations containing 2% and 5% of the medication are available. This OTC medication is regarded as safe; however, it should be used with caution.

Q. What is the effectiveness of Minoxidil for women?

Minoxidil is the only drug that is FDA-approved to treat female pattern baldness. It slows down or stops hair lossby prolonging the growth phase of the hair follicles.

Q. How to use minoxidil?

Minoxidil is a promising treatment for hereditary hair loss and androgenetic alopecia. A 5% minoxidil solution should be applied to a clean, dry scalp and gently massaged into the affected areas. After application, allow the scalp to remain dry for 2–4 hours for optimal absorption.

Q. Is minoxidil safe for hair?

Minoxidil is safe and FDA-approved and is widely used as a topical treatment for hair growth. However, it is always advisable to use it only on the recommendation of a healthcare professional, as some individuals may experience side effects.

Q. Who should avoid using minoxidil?

Minoxidil is a vasodilator and may cause problems in people with a history of heart disease. Individuals with eczema or known hypersensitivity to the medication, as well as women who are pregnant or breastfeeding, should also avoid using it.

Q. How long does minoxidil take to work?

Minoxidil does not work immediately; it generally takes 6–8 weeks to start showing effectiveness. However, results depend on the individual, and visible improvement typically appears within 3–6 months of consistent use.

Q. Does minoxidil work for a beard?

Minoxidil is well known as an effective treatment for scalp hair growth, and clinical studies show that it can also help to promote beard growth.

Q. What happens if I stop using minoxidil?

 Any hair you gained or kept thanks to minoxidil will gradually be lost, and your hair will return to the path it would have followed without treatment. This is not permanent damage. It is the loss of a benefit that depended on continued use. 

Q. How to apply minoxidil foam vs. solution?

  Minoxidil foam is applied directly to a dry scalp and gently massaged into the affected areas, while minoxidil solution is applied using a dropper for precise application. Both should be applied to a clean, dry scalp as directed on the product label. Allow minoxidil to dry completely and wash your hands after application. 

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