Security of Supply and COVID-19 Updates

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Measurably Superior Stearates

 

 

 

The world leader in high performance stearates

Mallinckrodt Pharmaceuticals (SpecGx LLC) is the world leader in the production of high-quality, reliably performing stearates for the pharmaceutical, nutraceutical, and food industries. Their stearates have been manufactured at their cGMP plant in St. Louis, MO for over a century using a unique water-based precipitation process to yield a consistent, “platelet-like” particle that is considered a true monohydrate. High purity pharmaceutical grade stearates are offered with the DMF to support your formulation work and food grade stearates are available with kosher, halal, and RSPO mass balance certifications. Mallinckrodt goes above and beyond global compendia requirements to ensure consistent performance by controlling additional physical parameters such as surface area, particle size, and bulk density. The result is measurably better stearates that provide better powder flowability and blend uniformity while avoiding capping, lamination, pitting, and sticking in tablets.

 

Types Available

  • Aluminum Monostearate
  • Calcium Stearate
  • Magnesium Stearate

Sources Available

  • Palm
  • Soy

 

 

Monographs Available

  • Food Chemical Codex (FCC)
  • National Formulary (NF)
  • European Pharmacopeia (EP)
  • British Pharmacopeia (BP)
  • Japanese Pharmacopeia (JP)
  • Chinese Pharmacopeia (ChP)

Certifications Available

  • Kosher for Passover
  • Halal
  • RSPO Mass Balance

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Products

 

Type

 

Product

 

Source

 

Specifications

 

Kosher for Passover

 

 

Halal

 

 

RSPO Mass Balance

 

 

Notes

 

Aluminum Monostearate

(CAS # 7047-84-9

 

HyQual™ 2263

 

Palm

 

NF

 

X

 

X

 

X

 

Promotes gelling in oil-based preparations

 

 

 

Calcium Stearate

(CAS # 1592-23-0)

 

HyQual™ 2248

 

Palm

 

NF, FCC

 

X

 

X

 

X

 

Standard particle size; works well with ibuprofen

 

HyQual™ 2249

 

Palm

 

NF

 

X

 

X

 

X

 

Fine powder, offering a smaller particle size option

 

Food Grade 5853

 

Palm

 

FCC

 

X

 

X

 

X

 

Food grade

 

 

 

 

 

 

 

Magnesium Stearate

(CAS # 557-04-0)

 

NF Veg 1726

 

Soy

 

NF, EP, BP, JP, FCC

 

X

 

X

 

N/A

 

Suitable for formulations with a larger particle size

 

HyQual™ 2257*

 

Palm

 

NF, EP, BP, JP, ChP, FCC

 

X

 

X

 

X

 

Most frequent choice for pharmaceutical applications

 

HyQual™ 5712*

 

Palm

 

NF, EP, BP, JP, ChP

 

X

 

X

 

X

 

Second most frequent choice for pharmaceutical applications, with a slightly smaller particle size than HyQual™ 2257

 

Stear-O-Wet™ 8577**

 

Palm

 

Magnesium Stearate: NF, EP, BP, JP, ChP, FCC

Sodium Lauryl Sulfate: NF

 

X

 

X

 

X

 

2-in-1 combination; spray-dried mixture of magnesium stearate and sodium lauryl sulfate

 

Nutraceutical 4024

 

Palm

 

NC

 

X

 

X

 

X

 

Nutraceutical grade

 

Food Grade 3508

 

Palm

 

FCC

 

X

 

X

 

X

 

Food grade

 

Powder 434 5774

 

Palm

 

 

 

 

X

 

Industrial grade fine particles

 

*Drug Master File (DMF) available for referencing
**DMF and Active Substance Master File (ADMF) available for referencing

 

Product highlight: Stear-O-Wet™

Stear-O-Wet™ is a spray-dried mixture of magnesium stearate and sodium lauryl sulfate. The addition of the sodium lauryl sulfate surfactant makes this product a hydrophilic magnesium stearate, reducing the uncertainty of attempting to dry blend the two in a consistent, homogeneous manner. Wettable formulations improve disintegration and dissolution of drug substances in tablets and are particularly useful in formulations with solubility issues. As such, Stear-O-Wet™ streamlines the supply chain in that manufacturers only need to source and stock one co-processed excipient instead of two separate ingredients.  Stear-O-Wet™ is uniform, avoiding the potential issue of over-blending if added separately, which can slow the rate of active ingredient dissolution due to the hydrophobic nature of magnesium stearate.

Applications

Food

Dough enhancer, dry mixes, hard candy, gum

Pharmaceuticals

Tablets, suppositories, injections, topicals

Nutraceuticals

Tablets, topicals

 

Univar Solutions is the premier distributor of food and pharmaceutical ingredients in North America

  • Vast network includes over 70 FDA-registered sites in North America
  • Efficient private fleet with dedicated drivers servicing local regions
  • Partnership with world class food and pharmaceutical ingredient manufacturers
  • Experienced technical sales force with broad ingredient and industry knowledge
  • Application development assistance available
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