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Magnesium Stearate (CAS 557-04-0) | USP-NF Tablet Lubricant & Glidant

Magnesium Stearate (CAS 557-04-0) | USP-NF Tablet Lubricant & Glidant

  • Magnesium Stearate (CAS 557-04-0) is a white, very fine, light powder with a characteristic greasy touch, widely used as a lubricant in tablet and capsule manufacturing.
  • It effectively reduces friction between the granulation and the die wall, ensuring smooth tablet ejection and uniform weight.
  • It also functions as an anti-adherent and glidant, preventing powder sticking to punches and improving flow properties.
  • Complies with USP43-NF38; batch-specific COA and MSDS available with every shipment.
  • Order(MOQ) :

    500kg
  • Product Origin :

    China
  • Color :

    White
  • Shipping Port :

    Shanghai, China
  • Lead Time :

    2-3 weeks
  • Weight :

    25kg
  • Cas No. :

    557-04-0
  • Molecular Formula :

    C₃₆H₇₀MgO₄ / Mg(C₁₈H₃₅O₂)₂
  • Appearance :

    White, very fine, light powder; greasy to touch
  • Application :

    Tablet lubricant, glidant and anti-adherent
 
  •  

Magnesium Stearate (CAS 557-04-0) is the magnesium salt of stearic acid, commercially supplied as a mixture of magnesium stearate and magnesium palmitate. It appears as a white, very fine, light powder that feels greasy to the touch and is practically insoluble in water, ethanol and ether.

As the most widely used lubricant in oral solid-dosage manufacturing, it reduces friction during compression and ejection, prevents sticking to tooling, and improves the flow of granulations into the die. It is also used as a flow aid and anti-caking agent in cosmetics, food and nutraceutical products.

 

Application Fields

1. Pharmaceutical Tablet & Capsule Manufacturing

Primary use as a lubricant, glidant and anti-adherent in compressed tablets, capsules and powder blends. Typical concentration: 0.25%–2.0% w/w.

2. Nutraceutical & Dietary Supplements

Added to vitamin, mineral and herbal supplement tablets to improve powder flow and prevent sticking during high-speed compression.

3. Cosmetics & Food

Used as a flow aid and anti-caking agent in powdered cosmetics (face powders, eyeshadows) and as an anti-caking/release agent in powdered food products.

Core Advantages

1. High-Performance Tablet Lubricant

At typical use levels of 0.25%–2.0%, magnesium stearate markedly reduces die-wall friction, lowers ejection force and prevents punch sticking, producing clean, uniform tablets with good surface finish.

2. Pharmacopoeia-Grade Quality

Meets USP43-NF38: Mg content 4.0%–5.0% (calc. on dried substance), stearic acid ≥ 40.0%, and stearic + palmitic acids ≥ 90.0%. Heavy metals (Pb, Cd, Ni) are tightly controlled. Batch COA and MSDS provided; third-party inspection supported.

3. Versatile & Well-Accepted

Compatible with the vast majority of active ingredients and excipients. Beyond pharma tablets, it is used in capsule filling, powdered cosmetics, food anti-caking and as a release agent.

Technical Specifications

 

Item

Specification

Test Standard / Remarks

Product Name

Magnesium Stearate

Magnesium salt of stearic/palmitic acids

CAS Number

557-04-0

EINECS 209-150-3

Molecular Formula

C₃₆H₇₀MgO₄  /  Mg(C₁₈H₃₅O₂)₂

—

Molecular Weight

591.24

—

Appearance

White, very fine, light powder; greasy to touch

Slight characteristic odor

Assay (Mg, on dried basis)

4.0% – 5.0%

Typical 4.6%

Stearic Acid

≥ 40.0%

Typical 42.2%

Stearic Acid + Palmitic Acid

≥ 90.0%

Typical 99.5%

Loss on Drying

≤ 6.0%

Typical 4.6%

Chloride / Sulphate

≤ 0.1% / ≤ 1.0%

Conforms

Heavy Metals

Pb ≤ 10 ppm; Cd ≤ 3 ppm; Ni ≤ 5 ppm

Conforms

Specific Surface Area

~ 5.9 m²/g

Typical value

Melting Point

~ 88 °C (softens / decomposes on heating)

ICSC 1403

Density

~ 1.02 g/cm³

—

Solubility

Practically insoluble in water, ethanol and ether; soluble in hot ethanol

—

Microbial Limits

TAMC ≤ 1000 CFU/g; TYMC ≤ 500 CFU/g; E. coli / Salmonella absent

Conforms

 

FAQ : 

Q1: What is Magnesium Stearate?
A: It is the magnesium salt of stearic acid (CAS 557-04-0), a white, greasy, very fine powder used mainly as a lubricant and glidant in tablet and capsule production.
 
Q2: How is it used in tablet manufacturing?
A: It is added at about 0.25%–2.0% at the final blending stage to reduce friction, ease tablet ejection and prevent powder from sticking to punches.
 
Q3: Is it soluble in water?
A: No. It is practically insoluble in water, ethanol and ether, but disperses readily in hot ethanol.
 
Q4: What is the minimum order quantity?
A: The MOQ is 500 kg. Packaging of 20 kg bags or drums is standard; jumbo bags are available on request.
 
Q5: Which pharmacopoeia does it comply with?
A: Our Magnesium Stearate meets USP43-NF38, with Mg content 4.0%–5.0% and stearic+palmitic acids ≥ 90.0%. A batch COA is supplied with each shipment.
 
Q6: Is magnesium stearate safe?
A: It is a widely used, GRAS-accepted excipient in oral pharmaceutical and food products. When used at recommended levels it is well tolerated.

 

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