Azeco Cosmeceuticals

Azelaic acid - cosmetic grade Haircare information file

When quality and reliability come first

Azepur99®

High purity cosmetic grade of 100% biobased azelaic acid, obtained from high refi ned Sunfl ower oil of European origin, COSMOS approved.

Product Information

Azepur99® cosmetic-grade based products are the standard for cosmetic product quality and assurance of global supply. It is COS- MOS approved.

Azelaic acid is a naturally occurring straight-chained saturated dicarboxylic acid naturally present in rye, wheat, and barley. According to its well known in the art ability to inhibite the action of 5-a-reductase type 1 enzym, mainly present in sebocytes but also in epider- mal and follicular keratinocytes, dermal papilla cells and sweat glands, azelaic acid can be successfull used in hair care products.

General information

INCI Name and Chemical Identification

AZELAIC ACID NONANEDIOIC ACID, CAS: 123-99-9

Appearance

White to off-white micronised powder 100%

Origin

biobased product obtained from Sunfl ower Oil

Azepur99® is obtained by oxidative cleavage of the double bond of oleic chain of the triglyceride of the Sunfl ower oil, according to the following reaction: R = H, alkyl group

Manufacturing Process

Purity

99% minimum

Soluble in glycols, glycerin and alcohols, easily dispersible in polar esters thanks to its unic particle size distribution

Solubility

Azepur99® can be used in gel-emulsions and both low and high viscosity w/o and o/w emulsions, organo-gels and microemulsions

Applications

Azepur99® is self-preserving Azepur99® has an excellent safety profi le

Cosmetic Properties

Recommended Dosage

3 – 10 % by weight

The standard for azelaic acid in pharma & cosmetics

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Azeco Cosmeceuticals — your preferred partner for the formulation of azelaic acid based hair care products

Azeco Cosmeceuticals is the world’s leading supplier of cosmetic-grade azelaic acid. We earned this distinction by providing excep tional purity levels (unic product in the world market having this feature), consistently reliable supply, and outstanding technical and regulatory support. Our high purity azelaic acid is manufactured and handled according to the ISO 9001:2015 certification. It is obtained by using a continuous process 24 hours a day, seven days a week. This not only ensures ready availability, it also eliminates the batch-to-batch in- consistencies often found in azelaic acid from other suppliers. Azelaic acid from Azeco Cosmeceuticals has European, 100% biobased and palm free origin and it is REACH (Registration Evaluation and Authorization of CHemicals) compliant. How Azepur99® works on hair Azelaic acid is a very potent 5-a-reductase inhibitor (type 1), the enzyme that converts testosterone into 5a-dihydrotestosterone, a major cause for alopecia areata and hair loss. Due to the relative absence of dihydrotestosterone, regression of the hair follicle will take place (the catagen stage) and subsequently hair generation will take place (the anagen stage). This enables the use of Azepur99® for hair regrowth. Significant research is available to demonstrate the ability of azelaic acid to suppress the scalp’s pro- duction of DHT (a.k.a. Dihydrotestosterone, the hormone generally accepted as the primary cause of Male Pattern Balding, and as a frequent factor in Female Hair Loss.

There is only a limited number of cosmetically allowed 5-a-reductase inhibitors available: saw palmetto, alfalfa, Japanese pagoda tree, red clover and the often praised Indian mulberry. The net effect of these botanicals is, however, limited and not at all compara- ble to azelaic acid.

According to Stamatiadis (see References) 5-a-reductase inhibition is already detectable at an azelaic acid concentration as low as 0,2 mMol/l. Inhibition is complete at a concentration of 3 mMol/l, equivalent to ~0,6 mg/l. Azelaic acid has also shown in the art interesting synergies with other physiologically active ingredients: Stamatiadis, using an in vitro assay with 1,2[3H]-testosterone as substrate, also studied the inhibitory effects of zinc sulfate (3-9 mMol/l) and Pyridoxine (vitamin B6) in combination with azelaic acid. His observations suggest the simultaneous use of the three products is really effective for the treatment of androgenic alopecia, being this indicative of a powerful synergy.

The powerful combination {azelaic acid + zinc sulphate + vitamin B6} for the treatment of androgenic alopecia is cosmetically suitable contrary to the steroidal and non-steroidal pharmaceutical preparations. In addition, azelaic acid has a superior toxicological profile.

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Ideal for a variety of products

Azepur99® is ideal for use in a variety of personal care products (also COSMOS / ECOCERT approved) for hair, providing important benefits that consumers desire. Here’s a brief overview:

Benefits/Clai

Applications

Anti hair thinning agent Stimulating the life cycle of the hair

It promotes the reactivation of silent follicles stimulating hair growth, promoting root regeneration, preventing hair loss Antioxidant and anti-inflammatory properties Keeping your scalp and hair follicles calm and functioning normally Able to combat oxidative stress, which can contribute to both balding and the premature aging of hair follicles Controlling hair loss and promoting new hair regrowth

Shampoos; hair care lotions for men and women, hair masks

Examples of hair care formulations based on Azepur99®

HC001 Detoxifying & Strengthening, DHT blocker Shampoo

It contains ingredients that inhibit DHT production and reduce the production of Alpha 5 Reductase, which is an enzyme that converts testosterone to DHT. This shampoo works to reduce excess DHT on the scalp, as well as unclog blocked pores, cleanse the scalp, improve blood flow in the scalp, and give hair a healthier general outlook.

INCI Name

Trade Name

% by Weight

Function

A Aqua

Water

To 100

Solvent

Zinc Sulfate

0.10

Astringent, antimicrobial agent

Hair conditioning and moisturizing

Pyridoxine HCL

Vitamin B6 Hydrochloride

0.5

REWOPOL SB FA 30D [1]

15.00

Cleanser

B Aqua (and) Disodium Laureth Sulfosuccinate

Aqua (and) Cocamidopropyl Betaine

Crodateric™ CAB30 [2]

10.00

Cleanser

Aqua (and) Sodium Lauroyl Sarcosinate

Crodasinic LS30 [2]

8.00

Cleanser

Glyceryl Oleate

TEGIN® O V [1]

1.00

Emulsifier

Tripelargonin

Matrilox CP601M [3]

2.00

Emollient

PEG-150 Distearate

REWOPAL® PEG 6000 DS A [1]

1.00

Emulsifier

Azelaic acid

3.00

Active ingredient

Azepur99®

Glycerin

Matrilox CG001M [3]

2.00

Humectant

Propanediol

Propylene Glycol

2.00

Humectant

C Sodium Hydroxide (and) Aqua

Sodium Hydroxide, 10% in water

q.s.

Neutralizer

D Phenoxyethanol, Sorbitan Caprylate

Nipaguard SCP [4]

1.00

Preservative

Aqua (and) Glycerin (and) Serenoa Serrulata Fruit Extract Fruitliquid Saw Palmetto [2]

0.10

Astringent, antioxidant

Parfum

0.15

Fragrance

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Suppliers : [1] Evonik [2] Croda Oleochemicals [3] Matrìca [4] Clariant / Nipa Preservatives

Shampoo Specifications: Appearance:

Viscous liquid White Characteristic pH 6 - 6.5 pH 5.2 Viscosity 2000 – 3000 mPas Viscosity 2,500 mPas

Colour: Odour: pH (Typical): Brookfield Viscosity (S4, 20 rpm, 25°C) Typical:

Manufacturing instructions: 1.Prepare Phase A by combining all ingredients listed under Part A. 2.Heat the solution to 80ºC while stirring. 3.Adjust the pH using the sodium hydroxide water solution as needed. 4.Add Part D ingredients one at a time into the combined mixture of Parts A, B, and C, with continued stirring. 5.Cool the batch slowly while continuing to stir, then add ingredients of Part E.

INCI list: Ingredients: Aqua, Disodium Laureth Sulfosuccinate, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Azelaic Acid, Propa- nediol, Tripelargonin, Glycerin, PEG-150 Distearate, Serenoa Serrulata, Pyridoxine HCL, Zinc Sulfate, Parfum, Sodium Hydroxide, Sorbitan Caprylate

Shelf life: 3 years after production, 12 months after opening. Store at ambient temperature, out of direct sun light.

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HC002 Follicle Renewal Spray Lotion

This spray lotion contains ingredients that inhibit DHT production and reduce the activity of Alpha-5 Reductase, an enzyme responsible for converting testosterone into DHT. The formulation helps remove excess DHT, unclog pores, improve blood circulation on the scalp, and promote healthier-looking hair.

INCI Name

Trade Name

% by Weight

Function

A Alcohol Denat

MIXETAN 100 [1]

40.00

Solvent

Azelaic Acid

5.00

Active Ingredient

Azepur99®

Aqua (and) lecithin (and) alcohol (and) sodium hydroxide (and) tocopherol

NATIPIDE II [2]

0.55

Emulsifier

Hair conditioning and moisturizing

Pyridoxine

Vitamin B6

0.10

B PEG-8 DIMETHICONE (and) PEG-14

SILWAX WS-4 [3]

5.00

Conditioning Agent

Aqua

Water

49.10

Humectant

Zinc Sulfate

-

0.05

Astringent, antimicrobial agent

C Parfum

Fragrance

0.20

Fragrance

Suppliers : [1] Alcoolital Srl [2] AVG [3] Siltech

Specifications: Appearance:

Clear liquid From colourless to slightly yellowish

Colour: Odour: pH (Typical): Brookfield Viscosity (S4, 20 rpm, 25°C) (Typical):

Characteristic Not applicable Not applicable Fluid

Manufacturing instructions: 1.Prepare Phase A by combining the ingredients and mix until homogeneous. 2.Prepare Phase B by combining the ingredients and mix until homogeneous. 3.Add Phase B to Phase A slowly, flushing very gently and waiting for the final phase to become homogeneous. 4.Add all the ingredients of Phase C to the obtained Phase A+B, mixing until homogeneous.

INCI list: Ingredients: Aqua, Alcohol Denat., Azelaic Acid, Peg-8 Dimethicone, PEG-14, Sodium Hydroxide, Tocopherol, Pyridoxine, Zinc Sulfa- te, Lecithin, Parfum

Shelf life: 3 years after production, 12 months after opening. Store at ambient temperature, out of direct sun light.

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Scalpcare Azepur99®, a 100% biobased, high-purity azelaic acid—represents the next generation of scalp care innovation. Sourced from high oleic sunflower oil of European origin and COSMOS certified, Azepur99® responds to the increasing demand for safe, natural, and effective active ingredients in personal care formulations. Scalp care, once overlooked in haircare protocols, has become a key factor in maintaining healthy, resilient hair. Functional Properties of Azepur99® Azepur99® exhibits multiple biofunctional benefits: 5- α -reductase inhibition: By blocking this enzyme, Azepur99® decreases the formation of DHT (dihydrotestosterone), a central factor in androgenetic alopecia. Anti-inflammatory and antioxidant action: Soothes inflamed follicles and protects against oxidative stress. Antimicrobial effects: Helps regulate scalp microbiota, reducing fungal and bacterial contributors to irritation and hair loss. These mechanisms support an optimal scalp environment, essential for hair follicle vitality and hair growth stimulation. Clinical Efficacy Study Evaluation of a 10% Azepur99® scalp serum over 90 days. To validate the efficacy of Azepur99® in a scalp care formulation, a 90-day clinical study was performed using a scalp serum containing 10% Azepur99®.

Study objectives The primary aims of the study were to evaluate: 1.Hair density improvement 2.Scalp barrier function and resilience 3.Reduction in scalp sensitivity and discomfort

Study design Duration: 90 consecutive days of daily application Participants: A mixed-gender panel of healthy adult volunteers experiencing scalp sensitivity and/or mild hair thinning Product tested: Serum containing 10% Azepur99® as the active ingredient Application protocol: Participants applied the product once daily to the scalp, following standardized instructions Methods of Evaluation A combination of instrumental techniques and subjective questionnaires was used to measure effectiveness: Hair density: Quantified using high-resolution scalp photography and trichoscopy to count hair strands per cm² Scalp barrier function: Measured via transepidermal water loss (TEWL) and corneometry Sensitivity: Evaluated through participant feedback, visual scaling of erythema and itching, and self-reported questionnaires Tolerability and user satisfaction: Tracked through regular interviews and observation by clinical dermatologists

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Results summary

Objective findings: +3% hair density increase on average after 90 days 74% of participants exhibited improved hair density

+14% increase in scalp barrier function, measured by improved TEWL and hydration markers -16% reduction in scalp sensitivity, including fewer reports of tightness, itching, or redness

Subjective results (questionnaire-based): 91.3% of users reported less hair fall during washing and combing 95.6% noted a visible improvement in scalp comfort 65.2% experienced reduced redness and irritation 73.9% were satisfied or very satisfied with the overall results 60.87% expressed interest in purchasing the product after the study 63.64% reported a complete absence of scalp sensitivity after 90 days

In addition, photographic evidence showed visual improvements in scalp appearance and hair density after both 30 and 90 days, reinforcing the quantitative outcomes.

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In Figure 1, the improvement of the scalp of three panelist treated with the Azepur®99 based serum in shown (picture were taken before the daily treatment and after 30 and 90 days of the daily treatment):

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The standard for azelaic acid in pharma & cosmetics

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References Available scientific evidences for the application of Azelaic acid in hair care formulations

1.Introduction to Hair Loss Research American Hair Loss Research 2.D. Stamatiadis, M.C. Bulteau-Portois, I. Mowszowicz, Inhibition of 5- α -reductase activity in human skin by zinc and azelaic acid. British Journal of Dermatology, 119, 627, 1988. 3.S. Sasmaz and O. Arican, Comparison of azelaic acid and anthralin for the therapy of patchy alopecia areata: a pilot study. American Journal of Clinical Dermatology, 2005; 6(6): 403-406. 4.S.H. Yoon, et al., A Study for Verification of Hair Growth Effect of Azelaic Acid and Vitamin B6, Journal of the Korean Society of Plastic and Reconstructive Surgeons, 2008; 35(5): 507-513.

For more information, visit https://azeco-cosmeceuticals.com/ or call +31 475 20 60 70

The information set forth herein is furnished free of charge and based on technical dat that Azeco Cosmeceuticals BV believes to be reliable. It is intended for use by persons having technical skill, at their own risk. Because conditions of use are outside our control, Azeco Cosmeceuticals makes no warranties, expressed or implied, and assumes no liability in connection with any use of this informa- tion. Nothing herein is to be taken as a license to operate under, or a recommendation to infringe any patents or patent applications.

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For technical and / or sales service contact

Azeco Cosmeceuticals BV | The Netherlands Customer service service@azeco-cosmeceuticals.com

www.azeco-cosmeceuticals.com