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POLYGLYKOL 3350 P

Polyglykol 3350 P is polyethylene glycol, supplied as a white powder.
Polyglykol 3350 P is soluble in water and polar organic solvents like acetone or methanol.
Polyglykol 3350 P has a wide range of applications across several industries for Polyglykol 3350 P excellent properties as a solvent, humectant, and plasticizer.

CAS Number: 25322-68-3
Linear Formula: H(OCH2CH2)nOH

Polyglycol 3350 P is a white waxy powder.
Polyglykol 3350 P is soluble in water and polar organic solvents like aceton or methanol.
The solidification point, of Polyglykol 3350 P is about 55°C.

Polyglykol 3350 P is a white powder for reconstitution.
Polyglykol 3350 P is a synthetic polyglykol having an average molecular weight of 3350.

The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value.
The chemical formula is HO(C2H4O)nH in which n represents the average number of oxyethylene groups.

Below 55°C, Polyglykol 3350 P is a free flowing white powder freely soluble in water.
Polyglykol 3350 P is an osmotic agent for the treatment of constipation.

Polyglykol 3350 P is non-volatile, slip and mold-release agent, solubilizer, thickener and anti-static agent.
Polyglykol 3350 P offers non-irritating, binding and softening properties.

Polyglykol 3350 P provides low toxicity and no emulsifying effect.
Polyglykol 3350 P offers very low water content and is compatible with hard water.

Polyglykol 3350 P is also used as a binder in bath salts and denture cleaners.
Polyglykol 3350 P is used in skin-care products.
Polyglykol 3350 P has a shelf life of 2 years.

Polyglykol 3350 P is particle size approx. 50–400 μm

Polyglykol 3350 P is a milled PEG API grade powder product, produced under ICH Q7 conditions with GMP certification by the German authorities.
The powder form supports the homogeneous mixing with other materials within production.
Polyglykol 3350 P is specified according to the requirements of the main international ICH guidelines and monographs.

Polyglykol 3350 P is a biocompatible inert synthetic polymer with repeating units of ether oxygen (-CH2-CH2-O-).
Polyglykol 3350 P can be synthesized via anionic polymerization of ethylene oxide.
Polyglykol 3350 P is extensively used in biological and medical applications due to Polyglykol 3350 P non-immunogenicity and high water solubility.

Polyglykol 3350 P is used in skin care.
Polyglykol 3350 P is acts as a slip and mold-release agent, solubilizer, carrier, thickener and antistatic agent.

Uses of Polyglykol 3350 P:
Polyglykol 3350 P can be used to functionalize magnetite nanoparticles.
The coating of the magnetic core with Polyglykol 3350 P provides good stabilization while maintaining the magnetic properties of the nanoparticles.

Polyglykol 3350 P can be used to modify the surface of photocatalytic TiO2 nanopowder for Polyglykol 3350 P application in self-cleaning paints.
Polyglykol 3350 P-coated TiO2 nanopowder can be prepared under mild conditions and show excellent colloidal stability.

Polyglykol 3350 P can be used as a cross-linker to prepare poly(N-isopropylacrylamide) based thermosensitive injectable hydrogels.
The addition of Polyglykol 3350 P improves the chemical and mechanical properties of hydrogel and prevents Polyglykol 3350 P from dissolving in the swelling medium.
Owing to their biocompatibility and biodegradability, these hydrogels are widely used for biomedical applications.

Usage Area of Polyglykol 3350 P:
Additive - Anti static agents
Solvents - Glycols glycol ethers - Ethylene glycols
Additive - Binders
Additive - Solubilizers
Additive - Lubricants
Additive - Rheology modifiers thickeners
Additive - Slip control agents

Advantages of Polyglykol 3350 P:
Posesses binding
softening and non irritating properties
Offers low toxicity
No emulsifying effect

Features and Benefits of Polyglykol 3350 P:
High structural flexibility
Biocompatibility
High hydration capacity
Devoid of any steric hindrance

Clinical Pharmacology of Polyglykol 3350 P:

Pharmacology:
Polyglykol 3350 P is an osmotic agent which causes water to be retained with the stool.
Essentially, complete recovery of Polyglykol 3350 P was shown in normal subjects without constipation.

Attempts at recovery of Polyglykol 3350 P in constipated patients resulted in incomplete and highly variable recovery.
In vitro study showed indirectly that Polyglykol 3350 P was not fermented into hydrogen or methane by the colonic microflora in human feces.

Polyglykol 3350 P appears to have no effect on the active absorption or secretion of glucose or electrolytes.
There is no evidence of tachyphylaxis.

Clinical Trials:
In one study, patients with less than 3 bowel movements per week were randomized to Polyglykol 3350 P, 17 grams, or placebo for 14 days.
An increase in bowel movement frequency was observed for both treatment groups during the first week of treatment.
Polyglykol 3350 P was statistically superior to placebo during the second week of treatment.

In another study, patients with 3 bowel movements or less per week and/or less than 300 grams of stool per week were randomized to 2 dose levels of Polyglykol 3350 P or placebo for 10 days each.
Success was defined by an increase in both bowel movement frequency and daily stool weight.
For both parameters, superiority of the 17 gram dose of Polyglykol 3350 P over placebo was demonstrated.

Indications and Usage:
For the treatment of occasional constipation.
Polyglykol 3350 P should be used for 2 weeks or less or as directed by a physician.

Contraindications:
Polyglykol 3350 P is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

Warnings:
Patients with symptoms suggestive of bowel obstruction (nausea, vomiting, abdominal pain or distention) should be evaluated to rule out this condition before initiating Polyethylene Glycol 3350 ...

Precautions:

General:
Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications.
A diagnostic evaluation should include a structural examination of the colon.
Patients should be educated about good defecatory and eating habits (such as high fiber diets) and lifestyle changes (adequate dietary fiber and fluid intake, regular exercise) which may produce more regular bowel habits.

Polyglykol 3350 P should be administered after being dissolved in approximately 4 - 8 ounces of water, juice, soda, coffee, or tea.

Information for Patients:
Polyglykol 3350 P softens the stool and increases the frequency of bowel movements by retaining water in the stool.
Polyglykol 3350 P should always be taken by mouth after being dissolved in 4 - 8 ounces of water, juice, soda, coffee, or tea.
Should unusual cramps, bloating, or diarrhea occur, consult your physician.

Two to 4 days may be required to produce a bowel movement.
Polyglykol 3350 P should be used for 2 weeks or less or as directed by a physician.
Prolonged, frequent or excessive use of Polyglykol 3350 P may result in electrolyte imbalance and dependence on laxatives.

Laboratory Tests:
No clinically significant effects on laboratory tests have been demonstrated.

Drug Interactions:
No specific drug interactions have been demonstrated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term carcinogenicity studies, genetic toxicity studies and reproductive toxicity studies in animals have not been performed with Polyglykol 3350 P.

Pregnancy Category C:
Animal reproductive studies have not been performed with Polyglykol 3350 P.
Polyglykol 3350 P is also not known whether Polyglykol 3350 P can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity.
Polyglykol 3350 P should only be administered to a pregnant woman if clearly needed.

Pediatric Use:
Safety and effectiveness in pediatric patients has not been established.

Geriatric Use:
There is no evidence for special considerations when Polyglykol 3350 P is administered to elderly patients.

In geriatric nursing home patients, a higher incidence of diarrhea occurred at the recommended 17 gram dose.
If diarrhea occurs, Polyglykol 3350 P should be discontinued.

Adverse Reactions:
Nausea, abdominal bloating, cramping and flatulence may occur.
High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients.

Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

Overdosage:
There have been no reports of accidental overdosage.
In the event of overdosage, diarrhea would be the expected major event.

If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result.
Medication should be terminated and free water administered.
The oral LD50 is >50 gm/kg in mice, rats and rabbits.

Dosage And Administration:
The usual dose is 17 grams (about 1 heaping tablespoonful) of powder per day (or as directed by physician) in 4 - 8 ounces of water, juice, soda, coffee, or tea.
Each bottle of Polyglykol 3350 P is supplied with a dosing cap marked to contain 17 grams of laxative powder when filled to the indicated line.

Two to 4 days (48 to 96 hours) may be required to produce a bowel movement.

Stability and Reactivity of Polyglykol 3350 P:

Reactivity:
No dangerous reaction known under conditions of normal use.

Chemical stability:
Stable under normal conditions.

Possibility of hazardous reactions:
Polyglykol 3350 P is not a dust explosion risk as supplied.
However the build-up of fine dust can lead to a risk of dust explosions.

Conditions to avoid:
Keep away from heat.
Keep away from flames and sparks.

Hazardous decomposition products:
When handled and stored appropriately, no dangerous decomposition products are known.

Handling and Storage of Polyglykol 3350 P:

Advice on protection against fire and explosion:
Take precautionary measures against build-up of electrostatic charges, e.g earthing during loading and off-loading operations.
Keep away from sources of ignition - No smoking.
Capable of dust explosion (method: Hartmann tube, spark ignition)

Advice on safe handling:
Wear suitable protective equipment.
Keep tightly closed in a dry and cool place.

Do not breathe vapours/dust.
Do not get in eyes or mouth or on skin.

Avoid dust formation.
Keep away from sources of ignition.
Lead off electrostatic charges.

Conditions for safe storage:
Keep only in the original container.

Further information on storage conditions:
Store in a cool, dry, well-ventilated area.
Keep container sealed when not in use.
Store away from flammable or combustible materials.

First Aid Measures of Polyglykol 3350 P:

General advice:
Remove/ Take off immediately all contaminated clothing.
Get medical advice/ attention if you feel unwell.

If inhaled:
Move the victim to fresh air.
Give oxygen or artificial respiration if needed.

Get immediate medical advice/ attention.
Never give anything by mouth to an unconscious person.

In case of skin contact:
Wash thoroughly with soap and water for 15 minutes.
If skin irritation occurs, seek medical attention.

In case of eye contact:
Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes.
Get medical attention immediately if irritation develops and persists.

If swallowed:
Immediately call a POISON CENTER/ doctor.

Most important symptoms and effects, both acute and delayed:
The possible symptoms known are those derived from the labelling.
No additional symptoms are known.

Notes to physician:
None known.

Firefighting Measures of Polyglykol 3350 P:

Suitable extinguishing media:
Water spray jet
Foam

Unsuitable extinguishing media: Dry powder
Carbon dioxide (CO2)
High volume water jet

Specific hazards during firefighting:

In case of fires, hazardous combustion gases are formed:
Carbon monoxide (CO)
Emits toxic fumes under fire conditions.

Polyglykol 3350 P presents no unusual fire or explosion hazards while sealed in a shipping container.
During usage, if a dust cloud is generated, organic powders have the potential to be explosive with static spark or flame initiation.

Further information:
Exercise caution when fighting any chemical fire.
Use NIOSH approved self-contained breathing apparatus and full protective clothing.

Special protective equipment for firefighters:
Self-contained breathing apparatus

Accidental Release Measures of Polyglykol 3350 P:

Personal precautions, protective equipment and emergency procedures:
Wear suitable protective equipment.
Pre-wet material with water to avoid dust formation.

Sweep or vacuum and place in sealable container for disposal.
Wear protective equipment and wash thoroughly after handling.
Flush residue with water.

Environmental precautions:
Do not allow to enter drains or waterways

Methods and materials for containment and cleaning up:
Take up mechanically.

Identifiers of Polyglykol 3350 P:
Linear Formula: H(OCH2CH2)nOH
CAS Number: 25322-68-3
MDL number: MFCD00081839
PubChem Substance ID: 24852064

Trade name: POLYGLYKOL 3350 P
Material number: 107914
CAS number: 25322-68-3
Synonyms: Polyglykol 3350 P Has No Synonyms
Primary product use: Pharma
Chemical family: polyethylene glycol HO-(CH2CH2)n-H, average molar weight 3350

Physical and Chemical Properties of Polyglykol 3350 P:
Appearance: powder
Colour: white
Odour: characteristic
pH: 5 - 7 (68 °F / 20 °C)
Concentration: 100 g/l
Freezing point: 127 - 135 °F / 53 - 57 °C
Boiling point: not determined

Flash point: 518 °F / 270 °C
Evaporation rate: Not applicable
Self-ignition: Method: VDI 2263 (Grewer)
Not applicable Coated on an inert carrier material: danger of
self-ignition above 110 °C
Burning number: 1 Does not catch fire
Vapour pressure: < 0.01 mbar (68 °F / 20 °C)
Relative vapour density: Not applicable
Density: approx. 1.2 g/cm3 (68 °F / 20 °C)
Method: DIN 51757
Bulk density: 400 - 500 kg/m3
Solubility(ies)
Water solubility: approx. 500 g/l (68 °F / 20 °C)
Solubility in other solvents: not tested.
Solvent: fat
Partition coefficient: noctanol/water: log Pow: < -1
Auto-ignition temperature: > 608 °F / > 320 °C
Decomposition temperature: 680 °F / 360 °C
Viscosity:
Viscosity, dynamic: Not applicable
Viscosity, kinematic: 79 - 92 mm2/s (68 °F / 20 °C)
50 % aqueous solution:
Oxidizing properties: Not applicable
Dust deflagration index (Kst): 125 m.b_/s

Dust explosion class: St1
Metal corrosion rate: Not applicable
Minimum ignition energy: 6 - 13 mJ
with inductive electrical resistance: 30 - 100 mJ
without inductive electrical resistance

Viscosity at 20°C (50 % w/w in water) mPas: 85 – 105
Flash point °C: 260
Molecular weight g/mol 3050 – 3685 solidification point °C: 53 – 57

Form: powder
Quality Level: 200
Mol wt: average Mn 3,350
pH: 4.5-7.5
Viscosity: 90 cSt(210 °F) (99 °C)(lit.)
mp: 54-58 °C (lit.)
Density: 1.204 g/mL at 25 °C
Ω-end: hydroxyl
α-end: hydroxyl
SMILES string: C(CO)O
InChI: 1S/C2H6O2/c3-1-2-4/h3-4H,1-2H2
InChI key: LYCAIKOWRPUZTN-UHFFFAOYSA-N

Other Descriptions of Polyglykol 3350 P:

Chemical Names:
Polyethylene glycol, average molar mass 3350 g/mol

Pharmacopoeia Name:
USP-NF: Polyethylene glycol 3350, J.P.: Macrogol 4000,

Physical appearance:
Powder, milled

Quality status:
API, ICH Q7; Kosher certificate

Application function:
Laxative API, Solvent, Ointment base, Coating agent, Binder

Industry:
Cosmetics

Chemical Composition:
Polyethylene glycol

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